Trial Outcomes & Findings for A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis (NCT NCT04040192)
NCT ID: NCT04040192
Last Updated: 2023-03-08
Results Overview
The duration of flare-free maintenance was the time from randomization to the last Investigator's Static Global Assessment (ISGA) and was right censored, if an intercurrent event (eg, death, dropout, loss to follow up, or end of study) occurred before the first flare. When a flare occurred first, the duration of flare free maintenance was the time from randomization to the first flare and was not censored. Duration of flare free maintenance was estimated using the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
620 participants
Primary outcome timeframe
From randomization to first flare or last ISGA assessment (up to 52 weeks)
Results posted on
2023-03-08
Participant Flow
A total of 620 participants signed the informed consent form and were enrolled in the study. 78 participants were screen failures who did not meet eligibility criteria. 542 participants were not screen failures, of which only 497 were assigned to study treatment.
Participant milestones
| Measure |
Crisaborole 2% Twice Daily (BID)
Participants with mild to moderate atopic dermatitis (AD) were administered crisaborole 2% ointment applied topically BID for maximum duration of up to 8 weeks in open label (OL) run-in period.
|
Vehicle Once Daily (QD)
Participants identified as responders during the OL period were randomized to receive vehicle applied topically once daily (QD) for 52 weeks in the double-blind (DB) maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with vehicle was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Open Label Run-in Period (up to 8 Weeks)
STARTED
|
497
|
0
|
0
|
|
Open Label Run-in Period (up to 8 Weeks)
COMPLETED
|
270
|
0
|
0
|
|
Open Label Run-in Period (up to 8 Weeks)
NOT COMPLETED
|
227
|
0
|
0
|
|
Double Blind Period (up to 52 Weeks)
STARTED
|
0
|
135
|
135
|
|
Double Blind Period (up to 52 Weeks)
COMPLETED
|
0
|
78
|
78
|
|
Double Blind Period (up to 52 Weeks)
NOT COMPLETED
|
0
|
57
|
57
|
Reasons for withdrawal
| Measure |
Crisaborole 2% Twice Daily (BID)
Participants with mild to moderate atopic dermatitis (AD) were administered crisaborole 2% ointment applied topically BID for maximum duration of up to 8 weeks in open label (OL) run-in period.
|
Vehicle Once Daily (QD)
Participants identified as responders during the OL period were randomized to receive vehicle applied topically once daily (QD) for 52 weeks in the double-blind (DB) maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with vehicle was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Open Label Run-in Period (up to 8 Weeks)
Adverse Event
|
18
|
0
|
0
|
|
Open Label Run-in Period (up to 8 Weeks)
Lost to Follow-up
|
14
|
0
|
0
|
|
Open Label Run-in Period (up to 8 Weeks)
Physician Decision
|
3
|
0
|
0
|
|
Open Label Run-in Period (up to 8 Weeks)
Protocol Violation
|
3
|
0
|
0
|
|
Open Label Run-in Period (up to 8 Weeks)
Withdrawal by Subject
|
8
|
0
|
0
|
|
Open Label Run-in Period (up to 8 Weeks)
Withdrawal by parent/guardian
|
18
|
0
|
0
|
|
Open Label Run-in Period (up to 8 Weeks)
Failure to meet randomization criteria
|
152
|
0
|
0
|
|
Open Label Run-in Period (up to 8 Weeks)
Other
|
11
|
0
|
0
|
|
Double Blind Period (up to 52 Weeks)
Adverse Event
|
0
|
3
|
1
|
|
Double Blind Period (up to 52 Weeks)
Lost to Follow-up
|
0
|
6
|
10
|
|
Double Blind Period (up to 52 Weeks)
Physician Decision
|
0
|
0
|
2
|
|
Double Blind Period (up to 52 Weeks)
Protocol Violation
|
0
|
1
|
3
|
|
Double Blind Period (up to 52 Weeks)
Withdrawal by Subject
|
0
|
6
|
11
|
|
Double Blind Period (up to 52 Weeks)
Withdrawal by parent/guardian
|
0
|
8
|
7
|
|
Double Blind Period (up to 52 Weeks)
Other
|
0
|
29
|
18
|
|
Double Blind Period (up to 52 Weeks)
Pregnancy
|
0
|
2
|
0
|
|
Double Blind Period (up to 52 Weeks)
Missing
|
0
|
2
|
5
|
Baseline Characteristics
Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
Baseline characteristics by cohort
| Measure |
Crisaborole 2% BID
n=497 Participants
Participants with mild to moderate AD were administered crisaborole 2% ointment applied topically BID for maximum duration of up to 8 weeks in OL run-in period. Participants identified as responders during the OL period were randomized to receive vehicle or crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period.
|
|---|---|
|
Age, Continuous
Crisaborole 2% BID
|
19.89 Years
STANDARD_DEVIATION 18.443 • n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Age, Continuous
Vehicle QD
|
21.76 Years
STANDARD_DEVIATION 20.373 • n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Age, Continuous
Crisaborole 2% QD
|
22.62 Years
STANDARD_DEVIATION 20.175 • n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Sex: Female, Male
Crisaborole 2% BID · Female
|
283 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Sex: Female, Male
Crisaborole 2% BID · Male
|
214 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Sex: Female, Male
Vehicle QD · Female
|
76 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Sex: Female, Male
Vehicle QD · Male
|
59 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Sex: Female, Male
Crisaborole 2% QD · Female
|
71 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Sex: Female, Male
Crisaborole 2% QD · Male
|
64 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Ethnicity (NIH/OMB)
Crisaborole 2% BID · Hispanic or Latino
|
54 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Ethnicity (NIH/OMB)
Crisaborole 2% BID · Not Hispanic or Latino
|
426 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Ethnicity (NIH/OMB)
Crisaborole 2% BID · Unknown or Not Reported
|
17 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Ethnicity (NIH/OMB)
Vehicle QD · Hispanic or Latino
|
10 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Ethnicity (NIH/OMB)
Vehicle QD · Not Hispanic or Latino
|
120 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Ethnicity (NIH/OMB)
Vehicle QD · Unknown or Not Reported
|
5 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Ethnicity (NIH/OMB)
Crisaborole 2% QD · Hispanic or Latino
|
19 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Ethnicity (NIH/OMB)
Crisaborole 2% QD · Not Hispanic or Latino
|
110 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Ethnicity (NIH/OMB)
Crisaborole 2% QD · Unknown or Not Reported
|
6 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% BID · American Indian or Alaska Native
|
2 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% BID · Asian
|
101 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% BID · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% BID · Black or African American
|
161 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% BID · White
|
204 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% BID · More than one race
|
18 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% BID · Unknown or Not Reported
|
10 Participants
n=497 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Vehicle QD · American Indian or Alaska Native
|
0 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Vehicle QD · Asian
|
27 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Vehicle QD · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Vehicle QD · Black or African American
|
47 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Vehicle QD · White
|
54 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Vehicle QD · More than one race
|
7 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Vehicle QD · Unknown or Not Reported
|
0 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% QD · American Indian or Alaska Native
|
2 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% QD · Asian
|
28 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% QD · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% QD · Black or African American
|
42 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% QD · White
|
55 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% QD · More than one race
|
4 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
|
Race (NIH/OMB)
Crisaborole 2% QD · Unknown or Not Reported
|
3 Participants
n=135 Participants • Here, number analyzed signifies number of participants evaluable for specified rows. i.e., Crisaborole 2% BID arm including all participants who were enrolled and received at least 1 dose of study intervention in OL run-in period and Vehicle QD and Crisaborole 2% QD arms including all participants who were randomized to the respective arms in DB period.
|
PRIMARY outcome
Timeframe: From randomization to first flare or last ISGA assessment (up to 52 weeks)Population: Evaluable-DB (Eval-DB) population included all randomized participants with success in ISGA (i.e., achieving a score of clear \[0\] or almost clear \[1\] with a \>=2 grade improvement from the run-in baseline) and Eczema Area Severity Index score (EASI50) criteria as responders at randomization and received at least 1 dose of study intervention in the DB period.
The duration of flare-free maintenance was the time from randomization to the last Investigator's Static Global Assessment (ISGA) and was right censored, if an intercurrent event (eg, death, dropout, loss to follow up, or end of study) occurred before the first flare. When a flare occurred first, the duration of flare free maintenance was the time from randomization to the first flare and was not censored. Duration of flare free maintenance was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period
|
30 Days
95% Confidence Interval 28 • Interval 28.0 to 56.0
|
111 Days
95% Confidence Interval 56 • Interval 56.0 to 224.0
|
—
|
PRIMARY outcome
Timeframe: Crisaborole 2% BID: From start of study intervention in OL period up to 8 weeks ; Vehicle QD and crisaborole 2% QD: From start of study intervention in DB period up to 28 days after last dose of study intervention (maximum of 56 weeks)Population: Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started on or after the treatment period start date and before end of study (at least 28 days after last dose of study intervention).
Outcome measures
| Measure |
Vehicle QD
n=497 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=135 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=135 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
109 Participants
|
49 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Up to maximum of 52 weeksPopulation: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period.
Flare - free days was the sum of the duration of flare-free maintenance during the DB maintenance period for each participant.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Number of Flare-Free Days During the DB Period
|
199.42 Days
Standard Error 11.824 • Interval 11.824 to
|
234.01 Days
Standard Error 12.323 • Interval 12.323 to
|
—
|
SECONDARY outcome
Timeframe: Up to maximum of 52 weeksPopulation: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period.
Flare was defined as an ISGA score of \>=2. The ISGA is a 5-point scale (range 0 to 4), reflecting a global assessment of AD severity based on erythema, induration/papulation, and oozing/crusting. ISGA score of 2: mild (faint pink erythema with mild induration/papulation and no oozing/crusting) 3: moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting) and 4: severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting).
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Number of Flares During the DB Period
|
1.00 Flares
Interval 0.0 to 6.0
|
1.00 Flares
Interval 0.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, '"Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and "Number Analyzed'' signifies participants evaluable for specified rows.
Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset(ISGA\>=2) during 52-week DB period evaluated among pruritus responders at randomization. Responders=participants with success in ISGA and EASI50 criteria. Pruritus response maintenance=maintenance of \>=50% improvement in pruritus from baseline obtained at randomization. If event (e.g., death, first flare\[ISGA \>=2\], lost to follow up or end of study) occurred before loss of pruritus response for first flare-free period, duration of pruritus response maintenance was time from randomization to last assessment and was censored. Here,pruritus response maintenance duration was presented for participants aged \>=12 years with OL baseline PP NRS \>=3, \>=4 and \>=3, \>=4 points reduction from OL baseline to randomization in PP NRS. PP NRS: Participants were asked to rate their itch at worst moment during previous 24 hours on a scale of 0 to 10; 0=no itch and 10=worst itch imaginable".
Outcome measures
| Measure |
Vehicle QD
n=25 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=37 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS
Baseline PP NRS >=3 and >=3 point reduction in PP NRS
|
NA Days
Interval 18.0 to
Median and upper limit of 95 % CI could not be estimated due to less number of participants with events.
|
164 Days
Interval 105.0 to
Upper limit of 95 % CI could not be estimated due to less number of participants with events.
|
—
|
|
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS
Baseline PP NRS >=4 and >=4 point reduction in PP NRS
|
NA Days
Interval 16.0 to
Median and upper limit of 95 % CI could not be estimated due to less number of participants with events.
|
309 Days
Interval 141.0 to
Upper limit of 95 % CI could not be estimated due to less number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset (ISGA\>=2) during 52-week DB period. Evaluated among pruritus responders at randomization. Responders were defined as participants with success in ISGA and EASI50 criteria. Pruritus response maintenance=maintenance of \>=50% improvement in pruritus from baseline that was obtained at randomization. If an event (e.g., death, first flare \[ISGA \>=2\], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period, duration of maintenance of pruritus response was time from randomization to last assessment and was censored. Here, pruritus response maintenance duration was presented for participants aged 6 to \<12 years with baseline PRIS \>=2 and \>=2 points reduction from baseline to randomization in PRIS. PRIS: a 5-point scale (range: 0=no itch to 4=worst itch imaginable) and was completed by participants.
Outcome measures
| Measure |
Vehicle QD
n=10 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=2 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged 6 to <12 Years With Baseline Patient Reported Itch Severity (PRIS) >=2 and >=2 Points Reduction in PRIS
|
NA Days
Interval 2.0 to
Median and upper limit of 95 % CI could not be estimated due to less number of participants with events.
|
133 Days
Interval 28.0 to 238.0
|
—
|
SECONDARY outcome
Timeframe: From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''number of participants analyzed'' signifies participants evaluable at specified rows.
Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset(ISGA\>=2)during52-weekDB period. Evaluated among pruritus responders (success in ISGA, EASI 50) at randomization. Pruritus response maintenance=maintenance of \>=50% improvement in pruritus from baseline obtained at randomization. If event(e.g., death, first flare\[ISGA \>=2\], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period, duration of maintenance of pruritus response was time from randomization to last assessment and was censored. Here, pruritus response maintenance duration was presented for participants aged 3 to \<6 months with OL baseline ORIS\>=3 or \>=4 and \>=3 or \>=4 points reduction from OL baseline to randomization in ORIS. Caregivers were asked to rate observation of their child's itch(scratching, rubbing) at worst moment during previous 24 hours on a scale of 0 to 10;0=no itch,10=worst itch imaginable.
Outcome measures
| Measure |
Vehicle QD
n=20 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=10 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months
Baseline ORIS Scale >=3 and >=3 point reduction
|
7 Days
Interval 4.0 to
Upper limit of 95 % CI could not be estimated due to insufficient number of participants with events.
|
NA Days
Interval 2.0 to
Median and upper limit of 95 % CI could not be estimated due to insufficient number of participants with events.
|
—
|
|
Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months
Baseline ORIS Scale >=4 and >=4 point reduction
|
8 Days
Interval 4.0 to
Upper limit of 95 % CI could not be estimated due to insufficient number of participants with events.
|
NA Days
Interval 2.0 to
Median and upper limit of 95 % CI could not be estimated due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: From randomization to loss of EASI response or onset of first flare or the last EASI assessment (up to maximum of 52 weeks)Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period.
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et +It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD. EASI response maintenance = score that does not lose more than 50% of achieved reduction from Day1/Baseline run-in EASI score.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period
|
198 Days
Interval 84.0 to
Upper limit of 95%CI could not be estimated due to insufficient number of participants with events.
|
NA Days
Interval 175.0 to
Upper limit of 95%CI could not be estimated due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: From randomization to loss of DLQI response or onset of first flare or the last assessment up to first flare (up to maximum of 52 weeks)Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''number of participants analyzed'' signifies participants evaluable for specified rows.
Duration of DLQI maintenance=time from randomization to loss of DLQI response during 52-week DB period for responders at randomization. If event(e.g., death, first flare\[ISGA \>=2\], lost to follow up or end of study) occurred before loss of DLQI response, duration of maintenance of DLQI response=time from randomization to last assessment and censored. Responders=participants with success in ISGA,EASI50 criteria. DLQI response maintenance=response that does not lose more than minimal clinical important difference. DLQI =10-item questionnaire, measured impact of skin disease in participants aged \>=16 years. Children's DLQI (CDLQI): participants aged 4 to15 years. Each question in DLQI and CDLQI evaluated on 4-point scale (range 0=not at all to 3=very much). Scores from10 items were added for DLQI/CDLQI total score, range:0 (not at all) to 30 (very much). Higher scores=more impact on quality of life of participants/children.
Outcome measures
| Measure |
Vehicle QD
n=105 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=105 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period
DLQI for participants >=16 years of age
|
NA Days
Interval 111.0 to
Median and upper limit of 95%CI could not be estimated due to insufficient number of participants with events.
|
NA Days
Interval 187.0 to
Median and upper limit of 95%CI could not be estimated due to insufficient number of participants with events.
|
—
|
|
Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period
Children's DLQI: participants 4-<16 yrs of age
|
NA Days
Interval 360.0 to
Median and upper limit of 95%CI could not be estimated due to insufficient number of participants with events.
|
NA Days
Interval 271.0 to
Median and upper limit of 95%CI could not be estimated due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: From randomization to loss POEM response or onset of first flare or the last assessment up to the first flare (up to maximum of 52 weeks)Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable for specified rows.
POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The total score ranged from 0 to 28, where higher score indicated greater severity. POEM response maintenance was defined as the response that does not lose more than minimal clinical important difference. Duration of POEM maintenance was time from randomization to loss of POEM response during 52-week DB period for responders at randomization. Responders were defined as participants with success in ISGA and EASI50 criteria. If an event (e.g., death, first flare \[ISGA \>=2\], lost to follow up, or end of study) occurred before loss of POEM response, duration of maintenance of POEM response was time from randomization to last assessment and was censored. Proxy POEM was used for participants aged 3 months to \<12 years.
Outcome measures
| Measure |
Vehicle QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=122 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period
Proxy POEM
|
20 Days
Interval 13.0 to 124.0
|
150 Days
Interval 33.0 to
Upper limit of 95%CI could not be estimated due to insufficient number of participants with events.
|
—
|
|
Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period
POEM
|
55 Days
Interval 25.0 to 222.0
|
180 Days
Interval 69.0 to 322.0
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Day 1), Week 4, Week 8 and Week 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
ISGA:5- point global assessment scale of AD severity, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. First flare period was the time from the onset of flare (ISGA\>=2) during DB maintenance period where the participant was switched to receive open-label crisaborole ointment 2%, BID for up to 12 weeks until resolution of flares.
Outcome measures
| Measure |
Vehicle QD
n=96 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=81 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Investigator's Static Global Assessment (ISGA) Score for the First Flare Period
Week 0
|
2.4 Units on a scale
Standard Deviation 0.51
|
2.3 Units on a scale
Standard Deviation 0.47
|
—
|
|
Investigator's Static Global Assessment (ISGA) Score for the First Flare Period
Week 4
|
2.2 Units on a scale
Standard Deviation 0.45
|
2.2 Units on a scale
Standard Deviation 0.41
|
—
|
|
Investigator's Static Global Assessment (ISGA) Score for the First Flare Period
Week 8
|
2.1 Units on a scale
Standard Deviation 0.33
|
2.4 Units on a scale
Standard Deviation 0.57
|
—
|
|
Investigator's Static Global Assessment (ISGA) Score for the First Flare Period
Week 12
|
2.3 Units on a scale
Standard Deviation 0.48
|
2.5 Units on a scale
Standard Deviation 0.52
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Day 1), Week 4, Week 8 and Week 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number of Participants Analyzed'' signifies participants evaluable at specified time points.
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema\[E\], induration/papulation\[I\], excoriation\[Ex\], lichenification\[L\]) and % body surface area(BSA) affected.Each of clinical signs scored separately for each of 4 body regions (head and neck\[h\], upper limbs\[u\], trunk\[t\] \[including axillae and groin\], lower limbs\[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1=mild; 2= moderate; 3= severe.EASI area score(A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et +It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.First flare period=time from onset of flare(ISGA\>=2) during DB maintenance period where participant was switched to receive open-label crisaborole ointment 2%,BID for up to 12 weeks until resolution of flares.
Outcome measures
| Measure |
Vehicle QD
n=96 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=81 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EASI Score for the First Flare Period
Week 0
|
6.53 Units on a scale
Standard Deviation 5.897
|
5.27 Units on a scale
Standard Deviation 3.933
|
—
|
|
EASI Score for the First Flare Period
Week 4
|
6.09 Units on a scale
Standard Deviation 5.471
|
5.02 Units on a scale
Standard Deviation 3.869
|
—
|
|
EASI Score for the First Flare Period
Week 8
|
4.84 Units on a scale
Standard Deviation 5.322
|
5.66 Units on a scale
Standard Deviation 4.459
|
—
|
|
EASI Score for the First Flare Period
Week 12
|
6.25 Units on a scale
Standard Deviation 4.546
|
6.56 Units on a scale
Standard Deviation 5.647
|
—
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Duration of flare period was average duration calculated from sum of durations divided by number of flares for each participant.
Outcome measures
| Measure |
Vehicle QD
n=96 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=81 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Duration (Days) of Flare Period
|
54.2 Days
Standard Deviation 28.77 • Interval 28.77 to
|
55.3 Days
Standard Deviation 35.73 • Interval 35.73 to
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Evaluable-OL (Eval-OL) population included all participants that received at least 1 dose of study intervention in the OL period.
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et +It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
Outcome measures
| Measure |
Vehicle QD
n=497 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period
Week 8
|
-52.86 Percent change
Standard Deviation 51.209
|
—
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period
Week 2
|
-31.44 Percent change
Standard Deviation 37.151
|
—
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period
Week 4
|
-38.52 Percent change
Standard Deviation 44.448
|
—
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period
Week 6
|
-45.35 Percent change
Standard Deviation 49.453
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et +It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=175 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 4
|
2.87 Percent change
Standard Deviation 72.981
|
-10.16 Percent change
Standard Deviation 61.161
|
407.52 Percent change
Standard Deviation 562.691
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 8
|
1.04 Percent change
Standard Deviation 95.062
|
34.26 Percent change
Standard Deviation 224.615
|
239.90 Percent change
Standard Deviation 321.514
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 12
|
-0.11 Percent change
Standard Deviation 126.465
|
-8.22 Percent change
Standard Deviation 93.118
|
401.37 Percent change
Standard Deviation 937.078
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 16
|
26.30 Percent change
Standard Deviation 156.188
|
27.98 Percent change
Standard Deviation 282.035
|
272.90 Percent change
Standard Deviation 314.387
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 20
|
26.38 Percent change
Standard Deviation 147.113
|
-45.44 Percent change
Standard Deviation 54.768
|
264.70 Percent change
Standard Deviation 341.948
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 24
|
-20.62 Percent change
Standard Deviation 78.665
|
6.94 Percent change
Standard Deviation 162.911
|
270.22 Percent change
Standard Deviation 314.301
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 28
|
19.17 Percent change
Standard Deviation 112.841
|
-33.04 Percent change
Standard Deviation 31.617
|
453.99 Percent change
Standard Deviation 848.739
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 32
|
13.57 Percent change
Standard Deviation 131.633
|
-19.33 Percent change
Standard Deviation 81.663
|
341.18 Percent change
Standard Deviation 500.843
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 36
|
-55.95 Percent change
Standard Deviation 51.052
|
211.13 Percent change
Standard Deviation 155.547
|
184.26 Percent change
Standard Deviation 195.695
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 40
|
10.00 Percent change
Standard Deviation 142.168
|
-12.94 Percent change
Standard Deviation 148.586
|
330.78 Percent change
Standard Deviation 447.039
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 44
|
-59.74 Percent change
Standard Deviation 34.119
|
127.56 Percent change
Standard Deviation 322.953
|
444.00 Percent change
Standard Deviation 505.329
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 48
|
-22.23 Percent change
Standard Deviation 87.761
|
-30.01 Percent change
Standard Deviation 72.497
|
390.33 Percent change
Standard Deviation 502.931
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
Week 52
|
-39.27 Percent change
Standard Deviation 72.619
|
-49.81 Percent change
Standard Deviation 56.391
|
250.13 Percent change
Standard Deviation 497.782
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day of DB period),Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to % BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et +It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
Outcome measures
| Measure |
Vehicle QD
n=73 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=57 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period
Week 0
|
484.69 Percent change
Standard Deviation 672.923
|
324.54 Percent change
Standard Deviation 484.380
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period
Week 4
|
294.83 Percent change
Standard Deviation 350.182
|
293.63 Percent change
Standard Deviation 461.044
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period
Week 8
|
245.70 Percent change
Standard Deviation 411.541
|
275.66 Percent change
Standard Deviation 447.181
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period
Week 12
|
196.69 Percent change
Standard Deviation 272.911
|
408.94 Percent change
Standard Deviation 665.204
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Number Analyzed'' signifies participants evaluable at specified time points.
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\], lichenification \[L\]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(\>0 to \<10%), 2(10 to \<30%), 3(30 to \<50%), 4(50 to \<70%), 5(70 to \<90%), 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + ExU + Lu) + 0.3\*At\*(Et +It + Ext + Lt) + 0.4\*Al\*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 4
|
-0.46 Percent change
Standard Deviation 67.355
|
-10.34 Percent change
Standard Deviation 61.699
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 8
|
-21.34 Percent change
Standard Deviation 59.257
|
10.36 Percent change
Standard Deviation 144.770
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 12
|
2.24 Percent change
Standard Deviation 143.094
|
-9.44 Percent change
Standard Deviation 100.314
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 16
|
-14.82 Percent change
Standard Deviation 50.412
|
-0.47 Percent change
Standard Deviation 109.386
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 20
|
200.00 Percent change
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
-74.29 Percent change
Standard Deviation 40.808
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 24
|
-35.57 Percent change
Standard Deviation 55.674
|
-10.82 Percent change
Standard Deviation 109.364
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 28
|
0.00 Percent change
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
-34.52 Percent change
Standard Deviation 48.824
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 32
|
-28.39 Percent change
Standard Deviation 62.657
|
-27.82 Percent change
Standard Deviation 94.806
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 40
|
2.19 Percent change
Standard Deviation 83.621
|
-47.60 Percent change
Standard Deviation 64.625
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 48
|
-27.27 Percent change
Standard Deviation 61.689
|
-39.13 Percent change
Standard Deviation 82.669
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 52
|
-54.33 Percent change
Standard Deviation 45.072
|
-59.87 Percent change
Standard Deviation 58.964
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 36
|
-67.86 Percent change
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
—
|
—
|
|
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
Week 44
|
-36.84 Percent change
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period.
ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD.
Outcome measures
| Measure |
Vehicle QD
n=497 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period
Baseline
|
2.7 Units on a scale
Standard Deviation 0.48
|
—
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period
Change at Week 4
|
-0.7 Units on a scale
Standard Deviation 0.84
|
—
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period
Change at Week 6
|
-0.9 Units on a scale
Standard Deviation 0.93
|
—
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period
Change at Week 8
|
-1.2 Units on a scale
Standard Deviation 1.04
|
—
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period
Change at Week 2
|
-0.5 Units on a scale
Standard Deviation 0.69
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Number Analyzed'' signifies participants evaluable at specified time points.
ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=175 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Baseline
|
0.6 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.49
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 4
|
0.2 Units on a scale
Standard Deviation 0.52
|
0.1 Units on a scale
Standard Deviation 0.49
|
1.7 Units on a scale
Standard Deviation 0.53
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 8
|
0.2 Units on a scale
Standard Deviation 0.50
|
0.1 Units on a scale
Standard Deviation 0.58
|
1.5 Units on a scale
Standard Deviation 0.55
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 12
|
0.1 Units on a scale
Standard Deviation 0.52
|
0.0 Units on a scale
Standard Deviation 0.54
|
1.5 Units on a scale
Standard Deviation 0.58
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 16
|
0.2 Units on a scale
Standard Deviation 0.46
|
-0.0 Units on a scale
Standard Deviation 0.53
|
1.6 Units on a scale
Standard Deviation 0.60
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 20
|
0.3 Units on a scale
Standard Deviation 0.75
|
0.2 Units on a scale
Standard Deviation 0.69
|
1.8 Units on a scale
Standard Deviation 0.68
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 24
|
0.0 Units on a scale
Standard Deviation 0.67
|
-0.1 Units on a scale
Standard Deviation 0.56
|
1.5 Units on a scale
Standard Deviation 0.61
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 28
|
0.3 Units on a scale
Standard Deviation 0.45
|
0.2 Units on a scale
Standard Deviation 0.41
|
1.6 Units on a scale
Standard Deviation 0.64
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 32
|
-0.0 Units on a scale
Standard Deviation 0.60
|
-0.1 Units on a scale
Standard Deviation 0.53
|
1.7 Units on a scale
Standard Deviation 0.53
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 36
|
0.4 Units on a scale
Standard Deviation 0.74
|
0.0 Units on a scale
Standard Deviation 0.00
|
1.5 Units on a scale
Standard Deviation 0.51
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 40
|
0.0 Units on a scale
Standard Deviation 0.57
|
0.0 Units on a scale
Standard Deviation 0.59
|
1.6 Units on a scale
Standard Deviation 0.67
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 44
|
-0.1 Units on a scale
Standard Deviation 0.64
|
0.3 Units on a scale
Standard Deviation 0.71
|
1.8 Units on a scale
Standard Deviation 0.68
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 48
|
0.1 Units on a scale
Standard Deviation 0.65
|
-0.0 Units on a scale
Standard Deviation 0.63
|
1.6 Units on a scale
Standard Deviation 0.68
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
Change at Week 52
|
0.0 Units on a scale
Standard Deviation 0.66
|
-0.0 Units on a scale
Standard Deviation 0.57
|
1.6 Units on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Number Analyzed'' signifies participants evaluable at specified time points.
ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Baseline
|
0.6 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.49
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 44
|
0.0 Units on a scale
Standard Deviation 0.00
|
0.7 Units on a scale
Standard Deviation 0.58
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 48
|
0.0 Units on a scale
Standard Deviation 0.66
|
-0.1 Units on a scale
Standard Deviation 0.64
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 52
|
0.0 Units on a scale
Standard Deviation 0.62
|
-0.0 Units on a scale
Standard Deviation 0.61
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 4
|
0.2 Units on a scale
Standard Deviation 0.54
|
0.1 Units on a scale
Standard Deviation 0.49
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 8
|
0.2 Units on a scale
Standard Deviation 0.50
|
0.1 Units on a scale
Standard Deviation 0.60
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 12
|
0.1 Units on a scale
Standard Deviation 0.55
|
-0.1 Units on a scale
Standard Deviation 0.54
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 16
|
0.2 Units on a scale
Standard Deviation 0.43
|
0.0 Units on a scale
Standard Deviation 0.52
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 20
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
-0.4 Units on a scale
Standard Deviation 0.55
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 24
|
0.0 Units on a scale
Standard Deviation 0.63
|
-0.1 Units on a scale
Standard Deviation 0.55
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 28
|
0.5 Units on a scale
Standard Deviation 0.71
|
0.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 32
|
-0.1 Units on a scale
Standard Deviation 0.64
|
-0.1 Units on a scale
Standard Deviation 0.53
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 36
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
Change at Week 40
|
0.0 Units on a scale
Standard Deviation 0.60
|
-0.1 Units on a scale
Standard Deviation 0.66
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
ISGA:5-point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding scalp). Score ranged:0 to 4,where 0=clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1=almost clear(trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2=mild(faint pink erythema with mild induration/papulation and no oozing/crusting), 3=moderate(pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4=severe(deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. The period for which OL crisaborole 2% ointment BID was initiated for treatment of flare developed during DB maintenance until resumption of DB treatment was defined as flare treatment period.
Outcome measures
| Measure |
Vehicle QD
n=96 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=81 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period
Change at Week 4
|
1.5 Units on a scale
Standard Deviation 0.54
|
1.5 Units on a scale
Standard Deviation 0.55
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period
Change at Week 8
|
1.3 Units on a scale
Standard Deviation 0.47
|
1.6 Units on a scale
Standard Deviation 0.74
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period
Change at Week 12
|
1.5 Units on a scale
Standard Deviation 0.53
|
1.6 Units on a scale
Standard Deviation 0.67
|
—
|
|
Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period
Change at Week 0
|
1.8 Units on a scale
Standard Deviation 0.57
|
1.7 Units on a scale
Standard Deviation 0.49
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day) Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period.
The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged \>=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged \>=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
Outcome measures
| Measure |
Vehicle QD
n=497 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period
Baseline
|
19.61 Percentage BSA
Standard Deviation 16.807 • Interval 16.807 to
|
—
|
—
|
|
Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period
Change at Week 2
|
-3.86 Percentage BSA
Standard Deviation 8.313 • Interval 8.313 to
|
—
|
—
|
|
Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period
Change at Week 4
|
-5.09 Percentage BSA
Standard Deviation 10.061 • Interval 10.061 to
|
—
|
—
|
|
Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period
Change at Week 6
|
-6.42 Percentage BSA
Standard Deviation 11.398 • Interval 11.398 to
|
—
|
—
|
|
Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period
Change at Week 8
|
-7.35 Percentage BSA
Standard Deviation 12.301 • Interval 12.301 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Number Analyzed'' signifies participants evaluable at specified time points.
The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged \>=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged \>=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=175 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 16
|
1.25 Percentage BSA
Standard Deviation 5.623
|
0.58 Percentage BSA
Standard Deviation 5.848
|
5.33 Percentage BSA
Standard Deviation 9.369
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 4
|
1.16 Percentage BSA
Standard Deviation 4.391
|
0.52 Percentage BSA
Standard Deviation 5.164
|
6.25 Percentage BSA
Standard Deviation 8.208
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 8
|
0.59 Percentage BSA
Standard Deviation 6.202
|
-0.19 Percentage BSA
Standard Deviation 6.659
|
4.65 Percentage BSA
Standard Deviation 8.568
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 12
|
1.20 Percentage BSA
Standard Deviation 6.821
|
0.26 Percentage BSA
Standard Deviation 6.093
|
6.17 Percentage BSA
Standard Deviation 9.801
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 20
|
-1.29 Percentage BSA
Standard Deviation 5.363
|
1.38 Percentage BSA
Standard Deviation 6.846
|
7.45 Percentage BSA
Standard Deviation 13.678
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 24
|
2.42 Percentage BSA
Standard Deviation 9.213
|
2.15 Percentage BSA
Standard Deviation 11.217
|
4.79 Percentage BSA
Standard Deviation 7.483
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 28
|
-0.30 Percentage BSA
Standard Deviation 6.323
|
-1.25 Percentage BSA
Standard Deviation 5.906
|
7.22 Percentage BSA
Standard Deviation 9.389
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 32
|
0.33 Percentage BSA
Standard Deviation 7.623
|
0.84 Percentage BSA
Standard Deviation 5.971
|
6.36 Percentage BSA
Standard Deviation 11.286
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 36
|
0.44 Percentage BSA
Standard Deviation 1.917
|
2.50 Percentage BSA
Standard Deviation 3.623
|
3.36 Percentage BSA
Standard Deviation 6.603
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 40
|
0.02 Percentage BSA
Standard Deviation 6.752
|
0.89 Percentage BSA
Standard Deviation 6.097
|
3.50 Percentage BSA
Standard Deviation 8.292
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 44
|
-2.56 Percentage BSA
Standard Deviation 4.889
|
0.57 Percentage BSA
Standard Deviation 2.524
|
5.71 Percentage BSA
Standard Deviation 7.559
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 48
|
-0.37 Percentage BSA
Standard Deviation 7.134
|
0.48 Percentage BSA
Standard Deviation 6.295
|
4.05 Percentage BSA
Standard Deviation 8.689
|
|
Change From Baseline in Treatable %BSA: DB Period
Baseline
|
5.25 Percentage BSA
Standard Deviation 9.588
|
5.22 Percentage BSA
Standard Deviation 7.170
|
—
|
|
Change From Baseline in Treatable %BSA: DB Period
Change at Week 52
|
-1.23 Percentage BSA
Standard Deviation 5.531
|
-1.91 Percentage BSA
Standard Deviation 5.411
|
4.20 Percentage BSA
Standard Deviation 8.835
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Number Analyzed'' signifies participants evaluable at specified time points.
The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged \>=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged \>=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 4
|
1.20 Percentage BSA
Standard Deviation 4.487
|
0.53 Percentage BSA
Standard Deviation 5.196
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 16
|
1.05 Percentage BSA
Standard Deviation 5.929
|
0.28 Percentage BSA
Standard Deviation 5.891
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 20
|
5.00 Percentage BSA
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
-0.60 Percentage BSA
Standard Deviation 9.659
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 28
|
-1.50 Percentage BSA
Standard Deviation 2.121
|
-3.00 Percentage BSA
Standard Deviation 12.728
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 32
|
0.40 Percentage BSA
Standard Deviation 8.581
|
0.91 Percentage BSA
Standard Deviation 5.669
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 36
|
-2.00 Percentage BSA
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
0.00 Percentage BSA
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 40
|
-0.46 Percentage BSA
Standard Deviation 7.881
|
1.17 Percentage BSA
Standard Deviation 6.153
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 44
|
-3.25 Percentage BSA
Standard Deviation 4.596
|
2.33 Percentage BSA
Standard Deviation 3.215
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 52
|
-1.50 Percentage BSA
Standard Deviation 7.365
|
-1.47 Percentage BSA
Standard Deviation 5.232
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Baseline
|
5.25 Percentage BSA
Standard Deviation 9.588
|
5.22 Percentage BSA
Standard Deviation 7.170
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 8
|
0.21 Percentage BSA
Standard Deviation 7.661
|
-0.10 Percentage BSA
Standard Deviation 6.954
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 12
|
0.96 Percentage BSA
Standard Deviation 6.161
|
0.05 Percentage BSA
Standard Deviation 6.309
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 24
|
2.46 Percentage BSA
Standard Deviation 8.669
|
3.09 Percentage BSA
Standard Deviation 13.575
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Free Period
Change at Week 48
|
-0.85 Percentage BSA
Standard Deviation 7.724
|
1.14 Percentage BSA
Standard Deviation 6.959
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged \>=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged \>=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
Outcome measures
| Measure |
Vehicle QD
n=96 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=81 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Change From Baseline in Treatable %BSA: First Flare Period
Change at Week 4
|
6.92 Percentage BSA
Standard Deviation 9.704
|
4.17 Percentage BSA
Standard Deviation 6.884
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Period
Change at Week 8
|
4.95 Percentage BSA
Standard Deviation 11.642
|
3.56 Percentage BSA
Standard Deviation 6.646
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Period
Change at Week 0
|
8.27 Percentage BSA
Standard Deviation 12.154
|
4.68 Percentage BSA
Standard Deviation 6.304
|
—
|
|
Change From Baseline in Treatable %BSA: First Flare Period
Change at Week 12
|
5.75 Percentage BSA
Standard Deviation 10.499
|
3.39 Percentage BSA
Standard Deviation 5.328
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day), Weeks 24 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
The investigators were required to draw the skin areas affected by AD for each participant in a body map and the most commonly affected BSA was documented.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=68 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period
Baseline
|
14.28 Percentage BSA affected
Standard Deviation 13.957
|
10.77 Percentage BSA affected
Standard Deviation 9.834
|
—
|
|
Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period
Change at Week 24
|
2.29 Percentage BSA affected
Standard Deviation 11.579
|
-0.20 Percentage BSA affected
Standard Deviation 3.919
|
1.75 Percentage BSA affected
Standard Deviation 3.304
|
|
Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period
Change at Week 52
|
-3.46 Percentage BSA affected
Standard Deviation 10.536
|
-4.95 Percentage BSA affected
Standard Deviation 7.731
|
0.71 Percentage BSA affected
Standard Deviation 16.649
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Outcome measures
| Measure |
Vehicle QD
n=275 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Severity of night time itch: Baseline
|
4.6 Units on a scale
Standard Deviation 3.02
|
—
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Severity of night time itch: Week 2
|
2.9 Units on a scale
Standard Deviation 2.21
|
—
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Severity of night time itch: Week 4
|
2.7 Units on a scale
Standard Deviation 2.25
|
—
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Severity of night time itch: Week 6
|
2.5 Units on a scale
Standard Deviation 2.16
|
—
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Severity of night time itch: Week 8
|
2.5 Units on a scale
Standard Deviation 2.19
|
—
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Frequency of night time itch: Baseline
|
4.4 Units on a scale
Standard Deviation 2.80
|
—
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Frequency of night time itch: Week 2
|
2.8 Units on a scale
Standard Deviation 2.20
|
—
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Frequency of night time itch: Week 4
|
2.7 Units on a scale
Standard Deviation 2.23
|
—
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Frequency of night time itch: Week 6
|
2.4 Units on a scale
Standard Deviation 2.15
|
—
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Frequency of night time itch: Week 8
|
2.4 Units on a scale
Standard Deviation 2.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Outcome measures
| Measure |
Vehicle QD
n=68 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=76 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=77 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 4
|
2.0 Units on a scale
Standard Deviation 1.83
|
1.2 Units on a scale
Standard Deviation 1.49
|
2.2 Units on a scale
Standard Deviation 1.87
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 8
|
1.6 Units on a scale
Standard Deviation 1.61
|
1.1 Units on a scale
Standard Deviation 1.59
|
2.0 Units on a scale
Standard Deviation 2.08
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 28
|
1.6 Units on a scale
Standard Deviation 1.69
|
1.2 Units on a scale
Standard Deviation 1.73
|
1.9 Units on a scale
Standard Deviation 1.84
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 32
|
1.4 Units on a scale
Standard Deviation 1.57
|
1.1 Units on a scale
Standard Deviation 1.74
|
2.2 Units on a scale
Standard Deviation 2.02
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 36
|
1.4 Units on a scale
Standard Deviation 1.56
|
1.1 Units on a scale
Standard Deviation 1.85
|
1.8 Units on a scale
Standard Deviation 1.94
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 40
|
1.4 Units on a scale
Standard Deviation 1.46
|
1.2 Units on a scale
Standard Deviation 1.95
|
2.2 Units on a scale
Standard Deviation 1.68
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 44
|
1.6 Units on a scale
Standard Deviation 1.69
|
1.2 Units on a scale
Standard Deviation 1.98
|
1.6 Units on a scale
Standard Deviation 1.52
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 48
|
1.6 Units on a scale
Standard Deviation 1.76
|
1.1 Units on a scale
Standard Deviation 1.93
|
1.7 Units on a scale
Standard Deviation 1.72
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 52
|
1.4 Units on a scale
Standard Deviation 1.69
|
1.2 Units on a scale
Standard Deviation 1.96
|
1.3 Units on a scale
Standard Deviation 1.12
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 4
|
1.9 Units on a scale
Standard Deviation 1.89
|
1.1 Units on a scale
Standard Deviation 1.43
|
2.2 Units on a scale
Standard Deviation 1.83
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 8
|
1.6 Units on a scale
Standard Deviation 1.71
|
1.1 Units on a scale
Standard Deviation 1.55
|
2.0 Units on a scale
Standard Deviation 2.10
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 12
|
1.5 Units on a scale
Standard Deviation 1.76
|
1.1 Units on a scale
Standard Deviation 1.64
|
2.1 Units on a scale
Standard Deviation 2.25
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 16
|
1.6 Units on a scale
Standard Deviation 1.87
|
1.2 Units on a scale
Standard Deviation 1.64
|
1.8 Units on a scale
Standard Deviation 1.97
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 20
|
1.6 Units on a scale
Standard Deviation 1.82
|
1.3 Units on a scale
Standard Deviation 1.82
|
2.0 Units on a scale
Standard Deviation 1.54
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 24
|
1.5 Units on a scale
Standard Deviation 1.71
|
1.2 Units on a scale
Standard Deviation 1.77
|
1.7 Units on a scale
Standard Deviation 1.69
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 28
|
1.5 Units on a scale
Standard Deviation 1.71
|
1.2 Units on a scale
Standard Deviation 1.70
|
1.7 Units on a scale
Standard Deviation 1.81
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 32
|
1.3 Units on a scale
Standard Deviation 1.56
|
1.0 Units on a scale
Standard Deviation 1.72
|
2.1 Units on a scale
Standard Deviation 1.84
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 36
|
1.3 Units on a scale
Standard Deviation 1.57
|
1.1 Units on a scale
Standard Deviation 1.82
|
1.8 Units on a scale
Standard Deviation 1.87
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 40
|
1.4 Units on a scale
Standard Deviation 1.53
|
1.2 Units on a scale
Standard Deviation 1.91
|
2.1 Units on a scale
Standard Deviation 1.81
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 44
|
1.5 Units on a scale
Standard Deviation 1.71
|
1.2 Units on a scale
Standard Deviation 1.95
|
1.5 Units on a scale
Standard Deviation 1.63
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 48
|
1.6 Units on a scale
Standard Deviation 1.78
|
1.1 Units on a scale
Standard Deviation 1.87
|
1.5 Units on a scale
Standard Deviation 1.66
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Week 52
|
1.3 Units on a scale
Standard Deviation 1.70
|
1.2 Units on a scale
Standard Deviation 1.98
|
1.3 Units on a scale
Standard Deviation 1.21
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Baseline
|
1.9 Units on a scale
Standard Deviation 1.71
|
1.8 Units on a scale
Standard Deviation 1.79
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 12
|
1.6 Units on a scale
Standard Deviation 1.74
|
1.1 Units on a scale
Standard Deviation 1.64
|
2.2 Units on a scale
Standard Deviation 2.18
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 16
|
1.7 Units on a scale
Standard Deviation 1.85
|
1.2 Units on a scale
Standard Deviation 1.70
|
1.9 Units on a scale
Standard Deviation 1.77
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 20
|
1.6 Units on a scale
Standard Deviation 1.86
|
1.3 Units on a scale
Standard Deviation 1.86
|
2.2 Units on a scale
Standard Deviation 1.57
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Severity of night time itch: Week 24
|
1.6 Units on a scale
Standard Deviation 1.71
|
1.2 Units on a scale
Standard Deviation 1.79
|
1.7 Units on a scale
Standard Deviation 1.72
|
|
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Frequency of night time itch: Baseline
|
1.9 Units on a scale
Standard Deviation 1.66
|
1.8 Units on a scale
Standard Deviation 1.79
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Outcome measures
| Measure |
Vehicle QD
n=41 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=39 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
Severity of night time itch: Week 0
|
2.0 Units on a scale
Standard Deviation 1.12
|
2.0 Units on a scale
Standard Deviation 2.32
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
Severity of night time itch: Week 4
|
2.0 Units on a scale
Standard Deviation 1.95
|
2.2 Units on a scale
Standard Deviation 2.18
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
Severity of night time itch: Week 8
|
2.2 Units on a scale
Standard Deviation 1.73
|
2.8 Units on a scale
Standard Deviation 2.60
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
Severity of night time itch: Week 12
|
1.8 Units on a scale
Standard Deviation 1.32
|
2.8 Units on a scale
Standard Deviation 2.03
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
Frequency of night time itch: Week 0
|
2.0 Units on a scale
Standard Deviation 1.13
|
2.0 Units on a scale
Standard Deviation 2.32
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
Frequency of night time itch: Week 4
|
2.0 Units on a scale
Standard Deviation 2.13
|
2.1 Units on a scale
Standard Deviation 2.11
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
Frequency of night time itch: Week 8
|
2.1 Units on a scale
Standard Deviation 1.96
|
2.6 Units on a scale
Standard Deviation 2.54
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
Frequency of night time itch: Week 12
|
1.3 Units on a scale
Standard Deviation 1.26
|
2.7 Units on a scale
Standard Deviation 2.09
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Outcome measures
| Measure |
Vehicle QD
n=68 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=76 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Baseline
|
1.9 Units on a scale
Standard Deviation 1.71
|
1.8 Units on a scale
Standard Deviation 1.79
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 4
|
2.0 Units on a scale
Standard Deviation 1.87
|
1.2 Units on a scale
Standard Deviation 1.49
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 8
|
1.8 Units on a scale
Standard Deviation 1.68
|
1.2 Units on a scale
Standard Deviation 1.64
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 12
|
1.5 Units on a scale
Standard Deviation 1.27
|
1.1 Units on a scale
Standard Deviation 1.72
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 16
|
1.7 Units on a scale
Standard Deviation 1.30
|
1.2 Units on a scale
Standard Deviation 1.84
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 20
|
1.6 Units on a scale
Standard Deviation 1.26
|
1.4 Units on a scale
Standard Deviation 1.99
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 24
|
1.6 Units on a scale
Standard Deviation 1.23
|
1.2 Units on a scale
Standard Deviation 1.92
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 28
|
1.6 Units on a scale
Standard Deviation 1.21
|
1.2 Units on a scale
Standard Deviation 1.86
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 32
|
1.5 Units on a scale
Standard Deviation 1.27
|
1.2 Units on a scale
Standard Deviation 1.99
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 36
|
1.5 Units on a scale
Standard Deviation 1.24
|
1.1 Units on a scale
Standard Deviation 2.02
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 40
|
1.6 Units on a scale
Standard Deviation 1.24
|
1.1 Units on a scale
Standard Deviation 2.08
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 44
|
1.9 Units on a scale
Standard Deviation 1.20
|
1.1 Units on a scale
Standard Deviation 2.26
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 48
|
1.5 Units on a scale
Standard Deviation 1.27
|
1.2 Units on a scale
Standard Deviation 2.24
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Severity of night time itch: Week 52
|
1.6 Units on a scale
Standard Deviation 1.35
|
1.2 Units on a scale
Standard Deviation 2.29
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Baseline
|
1.9 Units on a scale
Standard Deviation 1.66
|
1.8 Units on a scale
Standard Deviation 1.79
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 4
|
1.9 Units on a scale
Standard Deviation 1.93
|
1.1 Units on a scale
Standard Deviation 1.43
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 8
|
1.8 Units on a scale
Standard Deviation 1.80
|
1.1 Units on a scale
Standard Deviation 1.60
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 12
|
1.4 Units on a scale
Standard Deviation 1.31
|
1.1 Units on a scale
Standard Deviation 1.73
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 16
|
1.6 Units on a scale
Standard Deviation 1.29
|
1.2 Units on a scale
Standard Deviation 1.79
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 20
|
1.5 Units on a scale
Standard Deviation 1.16
|
1.3 Units on a scale
Standard Deviation 1.92
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 24
|
1.4 Units on a scale
Standard Deviation 1.21
|
1.2 Units on a scale
Standard Deviation 1.91
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 28
|
1.3 Units on a scale
Standard Deviation 1.19
|
1.2 Units on a scale
Standard Deviation 1.89
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 32
|
1.3 Units on a scale
Standard Deviation 1.24
|
1.1 Units on a scale
Standard Deviation 2.04
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 36
|
1.3 Units on a scale
Standard Deviation 1.22
|
1.1 Units on a scale
Standard Deviation 2.05
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 40
|
1.6 Units on a scale
Standard Deviation 1.37
|
1.1 Units on a scale
Standard Deviation 2.06
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 44
|
1.8 Units on a scale
Standard Deviation 1.22
|
1.2 Units on a scale
Standard Deviation 2.25
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 48
|
1.5 Units on a scale
Standard Deviation 1.32
|
1.3 Units on a scale
Standard Deviation 2.18
|
—
|
|
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Frequency of night time itch: Week 52
|
1.3 Units on a scale
Standard Deviation 1.38
|
1.2 Units on a scale
Standard Deviation 2.30
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain.
Outcome measures
| Measure |
Vehicle QD
n=266 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period
Baseline
|
2.6 Units on a scale
Standard Deviation 2.60
|
—
|
—
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period
Week 2
|
2.0 Units on a scale
Standard Deviation 1.96
|
—
|
—
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period
Week 4
|
1.9 Units on a scale
Standard Deviation 2.03
|
—
|
—
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period
Week 6
|
1.8 Units on a scale
Standard Deviation 2.08
|
—
|
—
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period
Week 8
|
1.7 Units on a scale
Standard Deviation 2.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain.
Outcome measures
| Measure |
Vehicle QD
n=68 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=76 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=77 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Baseline
|
1.1 Units on a scale
Standard Deviation 1.34
|
1.2 Units on a scale
Standard Deviation 1.74
|
—
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 4
|
1.1 Units on a scale
Standard Deviation 1.55
|
0.7 Units on a scale
Standard Deviation 1.27
|
1.6 Units on a scale
Standard Deviation 1.68
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 8
|
1.0 Units on a scale
Standard Deviation 1.09
|
1.0 Units on a scale
Standard Deviation 1.59
|
1.5 Units on a scale
Standard Deviation 2.00
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 12
|
1.1 Units on a scale
Standard Deviation 1.69
|
0.9 Units on a scale
Standard Deviation 1.62
|
1.5 Units on a scale
Standard Deviation 1.80
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 16
|
1.3 Units on a scale
Standard Deviation 1.90
|
1.1 Units on a scale
Standard Deviation 1.67
|
1.2 Units on a scale
Standard Deviation 1.30
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 20
|
1.0 Units on a scale
Standard Deviation 1.49
|
1.1 Units on a scale
Standard Deviation 1.81
|
1.8 Units on a scale
Standard Deviation 1.65
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 24
|
1.1 Units on a scale
Standard Deviation 1.52
|
1.0 Units on a scale
Standard Deviation 1.82
|
1.1 Units on a scale
Standard Deviation 1.53
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 28
|
1.0 Units on a scale
Standard Deviation 1.54
|
1.0 Units on a scale
Standard Deviation 1.78
|
1.8 Units on a scale
Standard Deviation 1.97
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 32
|
1.0 Units on a scale
Standard Deviation 1.53
|
0.8 Units on a scale
Standard Deviation 1.71
|
1.6 Units on a scale
Standard Deviation 1.76
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 36
|
1.1 Units on a scale
Standard Deviation 1.61
|
0.9 Units on a scale
Standard Deviation 1.78
|
1.2 Units on a scale
Standard Deviation 1.66
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 40
|
1.1 Units on a scale
Standard Deviation 1.49
|
1.1 Units on a scale
Standard Deviation 1.95
|
1.5 Units on a scale
Standard Deviation 1.85
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 44
|
1.1 Units on a scale
Standard Deviation 1.67
|
1.1 Units on a scale
Standard Deviation 1.99
|
1.2 Units on a scale
Standard Deviation 1.82
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 48
|
1.3 Units on a scale
Standard Deviation 1.64
|
0.9 Units on a scale
Standard Deviation 1.88
|
1.6 Units on a scale
Standard Deviation 2.00
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Week 52
|
1.0 Units on a scale
Standard Deviation 1.62
|
1.0 Units on a scale
Standard Deviation 1.99
|
1.1 Units on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain.
Outcome measures
| Measure |
Vehicle QD
n=41 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=39 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period
Week 8
|
1.3 Units on a scale
Standard Deviation 1.53
|
2.3 Units on a scale
Standard Deviation 2.15
|
—
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period
Week 12
|
2.0 Units on a scale
Standard Deviation 1.66
|
2.3 Units on a scale
Standard Deviation 2.05
|
—
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period
Week 0
|
1.2 Units on a scale
Standard Deviation 1.26
|
2.2 Units on a scale
Standard Deviation 2.01
|
—
|
|
AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period
Week 4
|
1.4 Units on a scale
Standard Deviation 1.75
|
1.7 Units on a scale
Standard Deviation 1.94
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain NRS. Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain.
Outcome measures
| Measure |
Vehicle QD
n=68 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=76 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Baseline
|
1.1 Units on a scale
Standard Deviation 1.34
|
1.2 Units on a scale
Standard Deviation 1.74
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 12
|
0.9 Units on a scale
Standard Deviation 1.17
|
1.0 Units on a scale
Standard Deviation 1.75
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 16
|
1.1 Units on a scale
Standard Deviation 1.28
|
1.1 Units on a scale
Standard Deviation 1.83
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 20
|
1.1 Units on a scale
Standard Deviation 1.18
|
1.1 Units on a scale
Standard Deviation 2.02
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 24
|
1.2 Units on a scale
Standard Deviation 1.36
|
1.0 Units on a scale
Standard Deviation 1.97
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 36
|
1.2 Units on a scale
Standard Deviation 1.44
|
1.0 Units on a scale
Standard Deviation 2.08
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 40
|
1.2 Units on a scale
Standard Deviation 1.43
|
1.1 Units on a scale
Standard Deviation 2.21
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 4
|
1.2 Units on a scale
Standard Deviation 1.58
|
0.7 Units on a scale
Standard Deviation 1.30
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 8
|
1.0 Units on a scale
Standard Deviation 1.16
|
1.0 Units on a scale
Standard Deviation 1.65
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 28
|
1.0 Units on a scale
Standard Deviation 1.35
|
1.0 Units on a scale
Standard Deviation 2.04
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 32
|
1.1 Units on a scale
Standard Deviation 1.41
|
1.0 Units on a scale
Standard Deviation 2.06
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 44
|
1.2 Units on a scale
Standard Deviation 1.48
|
1.1 Units on a scale
Standard Deviation 2.37
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 48
|
1.3 Units on a scale
Standard Deviation 1.43
|
1.0 Units on a scale
Standard Deviation 2.28
|
—
|
|
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Week 52
|
1.1 Units on a scale
Standard Deviation 1.46
|
1.0 Units on a scale
Standard Deviation 2.32
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
Patient/Observer Global Impression of Severity (PGIS/OGIS) is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants \>=12 years of age and OGIS was completed by the observer for participants 3 months-\<12 years of age.
Outcome measures
| Measure |
Vehicle QD
n=491 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Patient/Observer Global Impression of Severity Score: OL Run-in Period
>= 12 years of age: Week 4
|
3.1 Units on a scale
Standard Deviation 1.12
|
—
|
—
|
|
Patient/Observer Global Impression of Severity Score: OL Run-in Period
>= 12 years of age: Week 6
|
3.0 Units on a scale
Standard Deviation 1.16
|
—
|
—
|
|
Patient/Observer Global Impression of Severity Score: OL Run-in Period
>= 12 years of age: Week 8
|
3.0 Units on a scale
Standard Deviation 1.19
|
—
|
—
|
|
Patient/Observer Global Impression of Severity Score: OL Run-in Period
3 months to <12 years of age: Baseline
|
4.4 Units on a scale
Standard Deviation 1.20
|
—
|
—
|
|
Patient/Observer Global Impression of Severity Score: OL Run-in Period
3 months to <12 years of age: Week 2
|
3.3 Units on a scale
Standard Deviation 1.13
|
—
|
—
|
|
Patient/Observer Global Impression of Severity Score: OL Run-in Period
3 months to <12 years of age: Week 4
|
3.3 Units on a scale
Standard Deviation 1.15
|
—
|
—
|
|
Patient/Observer Global Impression of Severity Score: OL Run-in Period
3 months to <12 years of age: Week 6
|
3.2 Units on a scale
Standard Deviation 1.21
|
—
|
—
|
|
Patient/Observer Global Impression of Severity Score: OL Run-in Period
3 months to <12 years of age: Week 8
|
3.1 Units on a scale
Standard Deviation 1.19
|
—
|
—
|
|
Patient/Observer Global Impression of Severity Score: OL Run-in Period
>= 12 years of age: Baseline
|
3.8 Units on a scale
Standard Deviation 1.30
|
—
|
—
|
|
Patient/Observer Global Impression of Severity Score: OL Run-in Period
>= 12 years of age: Week 2
|
3.2 Units on a scale
Standard Deviation 1.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants \>=12 years of age and OGIS was completed by the observer for participants 3 months-\<12 years of age.
Outcome measures
| Measure |
Vehicle QD
n=126 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=122 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=89 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Baseline
|
2.6 Units on a scale
Standard Deviation 1.03
|
2.5 Units on a scale
Standard Deviation 0.90
|
—
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 4
|
2.7 Units on a scale
Standard Deviation 1.14
|
2.3 Units on a scale
Standard Deviation 0.97
|
3.0 Units on a scale
Standard Deviation 0.88
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 8
|
2.6 Units on a scale
Standard Deviation 0.93
|
2.2 Units on a scale
Standard Deviation 1.02
|
2.9 Units on a scale
Standard Deviation 1.10
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 12
|
2.7 Units on a scale
Standard Deviation 1.05
|
2.2 Units on a scale
Standard Deviation 0.98
|
3.1 Units on a scale
Standard Deviation 1.05
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 16
|
2.7 Units on a scale
Standard Deviation 1.15
|
2.3 Units on a scale
Standard Deviation 1.06
|
2.9 Units on a scale
Standard Deviation 1.21
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 20
|
2.7 Units on a scale
Standard Deviation 0.98
|
2.4 Units on a scale
Standard Deviation 1.23
|
3.0 Units on a scale
Standard Deviation 1.19
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 24
|
2.6 Units on a scale
Standard Deviation 1.06
|
2.4 Units on a scale
Standard Deviation 1.29
|
2.7 Units on a scale
Standard Deviation 1.16
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 28
|
2.7 Units on a scale
Standard Deviation 1.04
|
2.4 Units on a scale
Standard Deviation 1.21
|
3.1 Units on a scale
Standard Deviation 1.31
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 48
|
2.7 Units on a scale
Standard Deviation 1.27
|
2.4 Units on a scale
Standard Deviation 1.19
|
2.5 Units on a scale
Standard Deviation 1.10
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Baseline
|
2.6 Units on a scale
Standard Deviation 0.99
|
2.6 Units on a scale
Standard Deviation 0.83
|
—
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 28
|
2.4 Units on a scale
Standard Deviation 1.08
|
2.0 Units on a scale
Standard Deviation 0.66
|
2.5 Units on a scale
Standard Deviation 0.65
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 36
|
2.4 Units on a scale
Standard Deviation 1.18
|
2.0 Units on a scale
Standard Deviation 0.58
|
2.9 Units on a scale
Standard Deviation 1.06
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 48
|
2.2 Units on a scale
Standard Deviation 0.80
|
1.8 Units on a scale
Standard Deviation 0.53
|
2.8 Units on a scale
Standard Deviation 0.95
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 32
|
2.6 Units on a scale
Standard Deviation 1.07
|
2.4 Units on a scale
Standard Deviation 1.19
|
2.7 Units on a scale
Standard Deviation 1.30
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 36
|
2.7 Units on a scale
Standard Deviation 1.15
|
2.4 Units on a scale
Standard Deviation 1.29
|
2.6 Units on a scale
Standard Deviation 1.25
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 40
|
2.6 Units on a scale
Standard Deviation 1.12
|
2.4 Units on a scale
Standard Deviation 1.34
|
2.6 Units on a scale
Standard Deviation 1.00
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 44
|
2.6 Units on a scale
Standard Deviation 1.18
|
2.5 Units on a scale
Standard Deviation 1.21
|
2.4 Units on a scale
Standard Deviation 0.74
|
|
Patient/Observer Global Impression of Severity Score: DB Period
>= 12 years of age: Week 52
|
2.4 Units on a scale
Standard Deviation 1.19
|
2.3 Units on a scale
Standard Deviation 1.26
|
2.8 Units on a scale
Standard Deviation 0.35
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 4
|
2.6 Units on a scale
Standard Deviation 1.14
|
2.4 Units on a scale
Standard Deviation 0.93
|
3.0 Units on a scale
Standard Deviation 1.08
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 8
|
2.3 Units on a scale
Standard Deviation 1.13
|
2.4 Units on a scale
Standard Deviation 1.03
|
2.8 Units on a scale
Standard Deviation 1.10
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 12
|
2.3 Units on a scale
Standard Deviation 0.99
|
2.2 Units on a scale
Standard Deviation 0.73
|
2.9 Units on a scale
Standard Deviation 1.16
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 16
|
2.4 Units on a scale
Standard Deviation 1.14
|
2.1 Units on a scale
Standard Deviation 0.77
|
2.8 Units on a scale
Standard Deviation 1.13
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 20
|
2.4 Units on a scale
Standard Deviation 1.03
|
2.2 Units on a scale
Standard Deviation 0.88
|
2.7 Units on a scale
Standard Deviation 1.07
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 24
|
2.4 Units on a scale
Standard Deviation 1.04
|
2.3 Units on a scale
Standard Deviation 1.02
|
2.7 Units on a scale
Standard Deviation 0.76
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 32
|
2.1 Units on a scale
Standard Deviation 0.80
|
2.1 Units on a scale
Standard Deviation 0.64
|
2.7 Units on a scale
Standard Deviation 0.79
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 40
|
2.2 Units on a scale
Standard Deviation 0.74
|
2.1 Units on a scale
Standard Deviation 0.67
|
2.8 Units on a scale
Standard Deviation 1.18
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 44
|
2.3 Units on a scale
Standard Deviation 1.05
|
2.0 Units on a scale
Standard Deviation 0.64
|
3.0 Units on a scale
Standard Deviation 1.25
|
|
Patient/Observer Global Impression of Severity Score: DB Period
3 months to <12 years of age: Week 52
|
2.1 Units on a scale
Standard Deviation 1.00
|
1.7 Units on a scale
Standard Deviation 0.62
|
2.6 Units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants \>=12 years of age and OGIS was completed by the observer for participants 3 months-\<12 years of age.
Outcome measures
| Measure |
Vehicle QD
n=93 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=75 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Patient/Observer Global Impression of Severity Score: First Flare Period
>= 12 years of age: Week 4
|
2.9 Units on a scale
Standard Deviation 0.98
|
2.9 Units on a scale
Standard Deviation 1.14
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Period
>= 12 years of age: Week 8
|
3.1 Units on a scale
Standard Deviation 1.02
|
3.6 Units on a scale
Standard Deviation 1.17
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Period
>= 12 years of age: Week 12
|
3.3 Units on a scale
Standard Deviation 1.56
|
3.1 Units on a scale
Standard Deviation 1.50
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Period
3 months to <12 years of age: Week 0
|
2.8 Units on a scale
Standard Deviation 0.94
|
3.0 Units on a scale
Standard Deviation 0.79
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Period
>= 12 years of age: Week 0
|
2.8 Units on a scale
Standard Deviation 0.93
|
3.1 Units on a scale
Standard Deviation 1.10
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Period
3 months to <12 years of age: Week 4
|
3.0 Units on a scale
Standard Deviation 1.19
|
2.8 Units on a scale
Standard Deviation 0.90
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Period
3 months to <12 years of age: Week 8
|
2.9 Units on a scale
Standard Deviation 1.16
|
3.1 Units on a scale
Standard Deviation 1.03
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Period
3 months to <12 years of age: Week 12
|
2.8 Units on a scale
Standard Deviation 0.95
|
3.4 Units on a scale
Standard Deviation 0.79
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants \>=12 years of age and OGIS was completed by the observer for participants 3 months-\<12 years of age.
Outcome measures
| Measure |
Vehicle QD
n=126 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=122 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Baseline
|
2.6 Units on a scale
Standard Deviation 1.03
|
2.5 Units on a scale
Standard Deviation 0.90
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 4
|
2.7 Units on a scale
Standard Deviation 1.14
|
2.3 Units on a scale
Standard Deviation 0.98
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 8
|
2.6 Units on a scale
Standard Deviation 1.00
|
2.3 Units on a scale
Standard Deviation 1.05
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 12
|
2.6 Units on a scale
Standard Deviation 1.03
|
2.2 Units on a scale
Standard Deviation 1.03
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 16
|
2.6 Units on a scale
Standard Deviation 1.04
|
2.1 Units on a scale
Standard Deviation 1.00
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 20
|
2.7 Units on a scale
Standard Deviation 0.96
|
2.2 Units on a scale
Standard Deviation 1.10
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 24
|
2.7 Units on a scale
Standard Deviation 1.06
|
2.2 Units on a scale
Standard Deviation 1.11
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 28
|
2.7 Units on a scale
Standard Deviation 1.05
|
2.2 Units on a scale
Standard Deviation 1.07
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 32
|
2.6 Units on a scale
Standard Deviation 1.05
|
2.1 Units on a scale
Standard Deviation 1.02
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 40
|
2.7 Units on a scale
Standard Deviation 1.10
|
2.1 Units on a scale
Standard Deviation 1.10
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 44
|
2.7 Units on a scale
Standard Deviation 1.10
|
2.3 Units on a scale
Standard Deviation 1.24
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 52
|
2.6 Units on a scale
Standard Deviation 1.15
|
2.0 Units on a scale
Standard Deviation 1.25
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 4
|
2.6 Units on a scale
Standard Deviation 1.14
|
2.4 Units on a scale
Standard Deviation 0.93
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 8
|
2.5 Units on a scale
Standard Deviation 1.28
|
2.3 Units on a scale
Standard Deviation 0.98
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 12
|
2.3 Units on a scale
Standard Deviation 1.12
|
2.3 Units on a scale
Standard Deviation 0.78
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 16
|
2.4 Units on a scale
Standard Deviation 1.14
|
2.0 Units on a scale
Standard Deviation 0.84
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 20
|
2.3 Units on a scale
Standard Deviation 1.24
|
2.1 Units on a scale
Standard Deviation 0.83
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 24
|
2.3 Units on a scale
Standard Deviation 1.47
|
1.9 Units on a scale
Standard Deviation 0.59
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 28
|
2.4 Units on a scale
Standard Deviation 1.59
|
2.0 Units on a scale
Standard Deviation 0.57
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 32
|
1.8 Units on a scale
Standard Deviation 0.75
|
2.1 Units on a scale
Standard Deviation 0.58
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 40
|
2.0 Units on a scale
Standard Deviation 0.99
|
1.8 Units on a scale
Standard Deviation 0.60
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 48
|
2.1 Units on a scale
Standard Deviation 0.92
|
1.7 Units on a scale
Standard Deviation 0.41
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 36
|
2.7 Units on a scale
Standard Deviation 1.05
|
2.1 Units on a scale
Standard Deviation 1.08
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
>= 12 years of age: Week 48
|
2.6 Units on a scale
Standard Deviation 1.14
|
2.3 Units on a scale
Standard Deviation 1.28
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Baseline
|
2.6 Units on a scale
Standard Deviation 0.99
|
2.6 Units on a scale
Standard Deviation 0.83
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 36
|
2.6 Units on a scale
Standard Deviation 1.77
|
1.7 Units on a scale
Standard Deviation 0.56
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 44
|
2.7 Units on a scale
Standard Deviation 1.66
|
1.7 Units on a scale
Standard Deviation 0.56
|
—
|
|
Patient/Observer Global Impression of Severity Score: First Flare Free Period
3 months to <12 years of age: Week 52
|
1.5 Units on a scale
Standard Deviation 0.50
|
1.6 Units on a scale
Standard Deviation 0.65
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
Patient/Observer Global Impression of Change (PGIC/OGIC) is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants \>=12 years of age and OGIC was completed by the observer for participants 3 months-\<12 years of age.
Outcome measures
| Measure |
Vehicle QD
n=495 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Patient/Observer Global Impression of Change Score: OL Run-in Period
>= 12 years of age: Week 4
|
2.7 Units on a scale
Standard Deviation 1.32
|
—
|
—
|
|
Patient/Observer Global Impression of Change Score: OL Run-in Period
>= 12 years of age: Week 8
|
2.6 Units on a scale
Standard Deviation 1.46
|
—
|
—
|
|
Patient/Observer Global Impression of Change Score: OL Run-in Period
3 months to <12 years: Week 2
|
2.6 Units on a scale
Standard Deviation 1.21
|
—
|
—
|
|
Patient/Observer Global Impression of Change Score: OL Run-in Period
3 months to <12 years: Week 8
|
2.5 Units on a scale
Standard Deviation 1.57
|
—
|
—
|
|
Patient/Observer Global Impression of Change Score: OL Run-in Period
>= 12 years of age: Week 2
|
2.8 Units on a scale
Standard Deviation 1.17
|
—
|
—
|
|
Patient/Observer Global Impression of Change Score: OL Run-in Period
>= 12 years of age: Week 6
|
2.6 Units on a scale
Standard Deviation 1.36
|
—
|
—
|
|
Patient/Observer Global Impression of Change Score: OL Run-in Period
3 months to <12 years: Week 4
|
2.6 Units on a scale
Standard Deviation 1.36
|
—
|
—
|
|
Patient/Observer Global Impression of Change Score: OL Run-in Period
3 months to <12 years: Week 6
|
2.5 Units on a scale
Standard Deviation 1.50
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants \>=12 years of age and OGIC was completed by the observer for participants 3 months-\<12 years of age.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=101 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Baseline
|
1.8 Units on a scale
Standard Deviation 0.68
|
1.8 Units on a scale
Standard Deviation 0.75
|
—
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 4
|
1.9 Units on a scale
Standard Deviation 0.84
|
1.8 Units on a scale
Standard Deviation 0.76
|
3.7 Units on a scale
Standard Deviation 1.53
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 8
|
2.0 Units on a scale
Standard Deviation 0.74
|
1.9 Units on a scale
Standard Deviation 0.88
|
2.9 Units on a scale
Standard Deviation 1.38
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 12
|
2.0 Units on a scale
Standard Deviation 0.76
|
1.9 Units on a scale
Standard Deviation 1.00
|
3.1 Units on a scale
Standard Deviation 1.41
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 20
|
2.3 Units on a scale
Standard Deviation 1.10
|
1.6 Units on a scale
Standard Deviation 0.80
|
2.4 Units on a scale
Standard Deviation 1.03
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 28
|
2.2 Units on a scale
Standard Deviation 1.06
|
1.6 Units on a scale
Standard Deviation 0.80
|
3.4 Units on a scale
Standard Deviation 1.34
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 32
|
1.7 Units on a scale
Standard Deviation 0.72
|
1.8 Units on a scale
Standard Deviation 1.26
|
2.4 Units on a scale
Standard Deviation 1.19
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 36
|
1.9 Units on a scale
Standard Deviation 0.93
|
1.8 Units on a scale
Standard Deviation 0.66
|
2.4 Units on a scale
Standard Deviation 1.13
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 40
|
1.8 Units on a scale
Standard Deviation 0.91
|
1.8 Units on a scale
Standard Deviation 1.10
|
3.3 Units on a scale
Standard Deviation 1.58
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 44
|
1.8 Units on a scale
Standard Deviation 0.79
|
1.8 Units on a scale
Standard Deviation 0.75
|
3.2 Units on a scale
Standard Deviation 1.33
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Baseline
|
1.5 Units on a scale
Standard Deviation 0.60
|
1.6 Units on a scale
Standard Deviation 0.61
|
—
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 4
|
1.7 Units on a scale
Standard Deviation 0.95
|
2.0 Units on a scale
Standard Deviation 1.23
|
3.4 Units on a scale
Standard Deviation 1.62
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 8
|
1.5 Units on a scale
Standard Deviation 0.57
|
1.8 Units on a scale
Standard Deviation 0.98
|
2.8 Units on a scale
Standard Deviation 1.37
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 12
|
1.6 Units on a scale
Standard Deviation 0.68
|
1.5 Units on a scale
Standard Deviation 0.65
|
2.8 Units on a scale
Standard Deviation 1.15
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 16
|
1.8 Units on a scale
Standard Deviation 0.97
|
1.5 Units on a scale
Standard Deviation 0.58
|
2.6 Units on a scale
Standard Deviation 1.31
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 20
|
1.9 Units on a scale
Standard Deviation 0.72
|
1.4 Units on a scale
Standard Deviation 0.62
|
2.4 Units on a scale
Standard Deviation 0.80
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 52
|
1.6 Units on a scale
Standard Deviation 0.78
|
1.5 Units on a scale
Standard Deviation 0.60
|
2.3 Units on a scale
Standard Deviation 0.75
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 16
|
2.1 Units on a scale
Standard Deviation 1.00
|
1.8 Units on a scale
Standard Deviation 0.79
|
3.0 Units on a scale
Standard Deviation 1.32
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 24
|
1.7 Units on a scale
Standard Deviation 0.70
|
1.8 Units on a scale
Standard Deviation 1.10
|
2.9 Units on a scale
Standard Deviation 1.23
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 48
|
1.5 Units on a scale
Standard Deviation 0.63
|
1.9 Units on a scale
Standard Deviation 1.34
|
2.8 Units on a scale
Standard Deviation 1.42
|
|
Patient/Observer Global Impression of Change Score: DB Period
>= 12 years of age: Week 52
|
1.8 Units on a scale
Standard Deviation 0.76
|
1.6 Units on a scale
Standard Deviation 1.01
|
1.8 Units on a scale
Standard Deviation 0.86
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 24
|
1.7 Units on a scale
Standard Deviation 0.90
|
1.7 Units on a scale
Standard Deviation 0.77
|
2.3 Units on a scale
Standard Deviation 1.21
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 28
|
1.6 Units on a scale
Standard Deviation 0.73
|
1.4 Units on a scale
Standard Deviation 0.68
|
2.1 Units on a scale
Standard Deviation 1.03
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 32
|
1.9 Units on a scale
Standard Deviation 1.24
|
1.8 Units on a scale
Standard Deviation 1.09
|
2.7 Units on a scale
Standard Deviation 1.26
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 36
|
1.6 Units on a scale
Standard Deviation 0.51
|
1.5 Units on a scale
Standard Deviation 0.64
|
2.7 Units on a scale
Standard Deviation 1.28
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 40
|
1.9 Units on a scale
Standard Deviation 0.85
|
1.7 Units on a scale
Standard Deviation 0.87
|
2.8 Units on a scale
Standard Deviation 1.56
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 44
|
1.6 Units on a scale
Standard Deviation 0.51
|
1.8 Units on a scale
Standard Deviation 1.14
|
2.4 Units on a scale
Standard Deviation 0.73
|
|
Patient/Observer Global Impression of Change Score: DB Period
3 months to <12 years of age: Week 48
|
1.6 Units on a scale
Standard Deviation 0.67
|
1.6 Units on a scale
Standard Deviation 0.89
|
2.6 Units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants \>=12 years of age and OGIC was completed by the observer for participants 3 months-\<12 years of age.
Outcome measures
| Measure |
Vehicle QD
n=89 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=77 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Patient/Observer Global Impression of Change Score: First Flare Period
>= 12 years of age: Week 0
|
3.8 Units on a scale
Standard Deviation 1.56
|
3.1 Units on a scale
Standard Deviation 1.51
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Period
>= 12 years of age: Week 8
|
2.4 Units on a scale
Standard Deviation 0.51
|
3.2 Units on a scale
Standard Deviation 1.26
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Period
>= 12 years of age: Week 12
|
2.7 Units on a scale
Standard Deviation 0.58
|
3.7 Units on a scale
Standard Deviation 1.11
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Period
3 months to <12 years of age: Week 4
|
2.4 Units on a scale
Standard Deviation 0.95
|
2.6 Units on a scale
Standard Deviation 0.97
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Period
>= 12 years of age: Week 4
|
2.7 Units on a scale
Standard Deviation 1.42
|
2.9 Units on a scale
Standard Deviation 1.30
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Period
3 months to <12 years of age: Week 0
|
3.8 Units on a scale
Standard Deviation 1.84
|
3.3 Units on a scale
Standard Deviation 1.53
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Period
3 months to <12 years of age: Week 8
|
2.3 Units on a scale
Standard Deviation 0.97
|
3.0 Units on a scale
Standard Deviation 1.41
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Period
3 months to <12 years of age: Week 12
|
2.4 Units on a scale
Standard Deviation 0.55
|
4.5 Units on a scale
Standard Deviation 0.71
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants \>=12 years of age and OGIC was completed by the observer for participants 3 months-\<12 years of age.
Outcome measures
| Measure |
Vehicle QD
n=129 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=125 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 20
|
1.9 Units on a scale
Standard Deviation 0.64
|
1.5 Units on a scale
Standard Deviation 0.52
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 28
|
1.9 Units on a scale
Standard Deviation 0.69
|
1.4 Units on a scale
Standard Deviation 0.53
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 32
|
1.7 Units on a scale
Standard Deviation 0.60
|
1.6 Units on a scale
Standard Deviation 0.97
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 4
|
1.8 Units on a scale
Standard Deviation 0.97
|
2.0 Units on a scale
Standard Deviation 1.23
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 8
|
1.7 Units on a scale
Standard Deviation 0.62
|
1.8 Units on a scale
Standard Deviation 1.00
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 44
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
1.4 Units on a scale
Standard Deviation 0.55
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 52
|
1.1 Units on a scale
Standard Deviation 0.38
|
1.3 Units on a scale
Standard Deviation 0.49
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Baseline
|
1.8 Units on a scale
Standard Deviation 0.68
|
1.8 Units on a scale
Standard Deviation 0.75
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 4
|
2.0 Units on a scale
Standard Deviation 0.83
|
1.8 Units on a scale
Standard Deviation 0.76
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 8
|
2.1 Units on a scale
Standard Deviation 0.73
|
1.9 Units on a scale
Standard Deviation 0.90
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 12
|
2.0 Units on a scale
Standard Deviation 0.86
|
2.0 Units on a scale
Standard Deviation 1.04
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 16
|
2.3 Units on a scale
Standard Deviation 1.29
|
1.8 Units on a scale
Standard Deviation 0.76
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 24
|
1.8 Units on a scale
Standard Deviation 0.83
|
1.6 Units on a scale
Standard Deviation 0.80
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 36
|
2.0 Units on a scale
Standard Deviation 1.26
|
1.4 Units on a scale
Standard Deviation 0.53
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 40
|
1.7 Units on a scale
Standard Deviation 0.85
|
1.5 Units on a scale
Standard Deviation 0.58
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 44
|
2.1 Units on a scale
Standard Deviation 1.07
|
1.6 Units on a scale
Standard Deviation 0.73
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 48
|
1.5 Units on a scale
Standard Deviation 0.62
|
1.6 Units on a scale
Standard Deviation 1.10
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
>= 12 years of age: Week 52
|
1.7 Units on a scale
Standard Deviation 0.88
|
1.4 Units on a scale
Standard Deviation 0.50
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Baseline
|
1.5 Units on a scale
Standard Deviation 0.60
|
1.6 Units on a scale
Standard Deviation 0.61
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 12
|
1.7 Units on a scale
Standard Deviation 0.80
|
1.6 Units on a scale
Standard Deviation 0.62
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 16
|
1.6 Units on a scale
Standard Deviation 0.97
|
1.6 Units on a scale
Standard Deviation 0.63
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 20
|
1.7 Units on a scale
Standard Deviation 0.58
|
1.4 Units on a scale
Standard Deviation 0.73
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 24
|
1.6 Units on a scale
Standard Deviation 0.53
|
1.6 Units on a scale
Standard Deviation 0.84
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 28
|
1.0 Units on a scale
Standard Deviation 0.00
|
1.3 Units on a scale
Standard Deviation 0.71
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 32
|
1.6 Units on a scale
Standard Deviation 0.52
|
1.7 Units on a scale
Standard Deviation 0.90
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 36
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated as a single participant was analyzed.
|
1.5 Units on a scale
Standard Deviation 0.53
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 40
|
1.7 Units on a scale
Standard Deviation 0.76
|
1.3 Units on a scale
Standard Deviation 0.46
|
—
|
|
Patient/Observer Global Impression of Change Score: First Flare Free Period
3 months to <12 years of age: Week 48
|
1.5 Units on a scale
Standard Deviation 0.55
|
1.3 Units on a scale
Standard Deviation 0.49
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
The Medical Outcomes Study (MOS) Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Outcome measures
| Measure |
Vehicle QD
n=273 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Short of Breath or Headache score: Baseline
|
27.8 Units on a scale
Standard Deviation 15.18
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Disturbance Score: Baseline
|
45.0 Units on a scale
Standard Deviation 21.27
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Somnolence Score: Baseline
|
44.9 Units on a scale
Standard Deviation 18.01
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Problems Index I Score: Baseline
|
38.3 Units on a scale
Standard Deviation 14.74
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Quantity Hours Slept Score: Baseline
|
7.4 Units on a scale
Standard Deviation 3.27
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Quantity Hours Slept Score: Week 2
|
7.6 Units on a scale
Standard Deviation 3.06
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Quantity Hours Slept Score: Week 4
|
7.6 Units on a scale
Standard Deviation 3.24
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Quantity Hours Slept Score: Week 6
|
7.9 Units on a scale
Standard Deviation 3.43
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Quantity Hours Slept Score: Week 8
|
7.8 Units on a scale
Standard Deviation 3.41
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Optimal Hours Slept Score: Baseline
|
0.4 Units on a scale
Standard Deviation 0.50
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Optimal Hours Slept Score: Week 2
|
0.5 Units on a scale
Standard Deviation 0.50
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Optimal Hours Slept Score: Week 4
|
0.5 Units on a scale
Standard Deviation 0.50
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Optimal Hours Slept Score: Week 6
|
0.5 Units on a scale
Standard Deviation 0.50
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Optimal Hours Slept Score: Week 8
|
0.5 Units on a scale
Standard Deviation 0.50
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Short of Breath or Headache score: Week 2
|
27.6 Units on a scale
Standard Deviation 13.98
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Short of Breath or Headache score: Week 4
|
27.0 Units on a scale
Standard Deviation 14.56
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Short of Breath or Headache score: Week 6
|
27.0 Units on a scale
Standard Deviation 13.95
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Short of Breath or Headache score: Week 8
|
26.4 Units on a scale
Standard Deviation 14.00
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Snoring Score: Baseline
|
43.3 Units on a scale
Standard Deviation 27.34
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Snoring Score: Week 2
|
41.1 Units on a scale
Standard Deviation 26.73
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Snoring Score: Week 4
|
41.0 Units on a scale
Standard Deviation 26.02
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Snoring Score: Week 6
|
40.9 Units on a scale
Standard Deviation 26.44
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Snoring Score: Week 8
|
40.5 Units on a scale
Standard Deviation 26.09
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Disturbance Score: Week 2
|
40.0 Units on a scale
Standard Deviation 20.21
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Disturbance Score: Week 4
|
40.3 Units on a scale
Standard Deviation 21.20
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Disturbance Score: Week 6
|
38.5 Units on a scale
Standard Deviation 20.25
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Disturbance Score: Week 8
|
38.6 Units on a scale
Standard Deviation 20.93
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Adequacy Score: Baseline
|
63.0 Units on a scale
Standard Deviation 19.99
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Adequacy Score: Week 2
|
66.1 Units on a scale
Standard Deviation 20.64
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Adequacy Score: Week 4
|
65.5 Units on a scale
Standard Deviation 20.67
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Adequacy Score: Week 6
|
66.8 Units on a scale
Standard Deviation 20.12
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Adequacy Score: Week 8
|
67.3 Units on a scale
Standard Deviation 20.33
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Somnolence Score: Week 2
|
42.5 Units on a scale
Standard Deviation 17.19
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Somnolence Score: Week 4
|
42.5 Units on a scale
Standard Deviation 18.12
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Somnolence Score: Week 6
|
42.5 Units on a scale
Standard Deviation 17.93
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Somnolence Score: Week 8
|
42.5 Units on a scale
Standard Deviation 19.08
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Problems Index I Score: Week 2
|
35.3 Units on a scale
Standard Deviation 13.83
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Problems Index I Score: Week 4
|
36.1 Units on a scale
Standard Deviation 14.97
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Problems Index I Score: Week 6
|
34.9 Units on a scale
Standard Deviation 14.08
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Problems Index I Score: Week 8
|
34.7 Units on a scale
Standard Deviation 14.03
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Problems Index II Score: Baseline
|
41.5 Units on a scale
Standard Deviation 15.39
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Problems Index II Score: Week 2
|
37.7 Units on a scale
Standard Deviation 14.67
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Problems Index II Score: Week 4
|
38.1 Units on a scale
Standard Deviation 15.73
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Problems Index II Score: Week 6
|
36.9 Units on a scale
Standard Deviation 14.82
|
—
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Sleep Problems Index II Score: Week 8
|
36.6 Units on a scale
Standard Deviation 15.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Outcome measures
| Measure |
Vehicle QD
n=69 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=78 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=88 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 8
|
32.9 Units on a scale
Standard Deviation 13.80
|
35.3 Units on a scale
Standard Deviation 15.70
|
39.8 Units on a scale
Standard Deviation 20.46
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 16
|
8.2 Units on a scale
Standard Deviation 3.89
|
8.1 Units on a scale
Standard Deviation 4.35
|
8.4 Units on a scale
Standard Deviation 3.80
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 20
|
6.9 Units on a scale
Standard Deviation 1.28
|
7.3 Units on a scale
Standard Deviation 1.49
|
8.9 Units on a scale
Standard Deviation 3.83
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 32
|
9.2 Units on a scale
Standard Deviation 5.64
|
8.3 Units on a scale
Standard Deviation 3.70
|
7.8 Units on a scale
Standard Deviation 4.25
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 36
|
6.9 Units on a scale
Standard Deviation 1.58
|
7.2 Units on a scale
Standard Deviation 1.48
|
7.4 Units on a scale
Standard Deviation 0.98
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 48
|
7.6 Units on a scale
Standard Deviation 3.88
|
7.7 Units on a scale
Standard Deviation 3.06
|
8.2 Units on a scale
Standard Deviation 5.29
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 52
|
7.7 Units on a scale
Standard Deviation 4.30
|
7.7 Units on a scale
Standard Deviation 3.12
|
7.5 Units on a scale
Standard Deviation 4.93
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Baseline
|
0.5 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.50
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 4
|
0.6 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.50
|
0.5 Units on a scale
Standard Deviation 0.50
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 8
|
0.7 Units on a scale
Standard Deviation 0.47
|
0.6 Units on a scale
Standard Deviation 0.49
|
0.5 Units on a scale
Standard Deviation 0.51
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 12
|
0.4 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.50
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 16
|
0.5 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.51
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 36
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.6 Units on a scale
Standard Deviation 0.51
|
0.7 Units on a scale
Standard Deviation 0.49
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 40
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.4 Units on a scale
Standard Deviation 0.49
|
0.1 Units on a scale
Standard Deviation 0.35
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 52
|
0.4 Units on a scale
Standard Deviation 0.49
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.4 Units on a scale
Standard Deviation 0.51
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Baseline
|
24.1 Units on a scale
Standard Deviation 9.44
|
27.2 Units on a scale
Standard Deviation 15.45
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 4
|
23.8 Units on a scale
Standard Deviation 11.85
|
23.9 Units on a scale
Standard Deviation 9.81
|
27.1 Units on a scale
Standard Deviation 13.16
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 8
|
24.4 Units on a scale
Standard Deviation 10.81
|
25.2 Units on a scale
Standard Deviation 12.66
|
27.4 Units on a scale
Standard Deviation 17.03
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 12
|
25.0 Units on a scale
Standard Deviation 10.16
|
26.5 Units on a scale
Standard Deviation 13.16
|
28.1 Units on a scale
Standard Deviation 15.95
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 16
|
26.2 Units on a scale
Standard Deviation 12.87
|
25.0 Units on a scale
Standard Deviation 11.11
|
22.9 Units on a scale
Standard Deviation 9.56
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 24
|
27.6 Units on a scale
Standard Deviation 15.88
|
27.7 Units on a scale
Standard Deviation 13.55
|
25.7 Units on a scale
Standard Deviation 12.22
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 28
|
27.8 Units on a scale
Standard Deviation 19.57
|
29.4 Units on a scale
Standard Deviation 18.86
|
30.0 Units on a scale
Standard Deviation 15.19
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 32
|
26.5 Units on a scale
Standard Deviation 12.76
|
23.1 Units on a scale
Standard Deviation 10.41
|
29.2 Units on a scale
Standard Deviation 15.53
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 36
|
25.9 Units on a scale
Standard Deviation 11.76
|
23.5 Units on a scale
Standard Deviation 14.55
|
22.9 Units on a scale
Standard Deviation 7.56
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 40
|
25.3 Units on a scale
Standard Deviation 12.37
|
26.0 Units on a scale
Standard Deviation 13.13
|
30.0 Units on a scale
Standard Deviation 21.38
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 44
|
28.9 Units on a scale
Standard Deviation 17.11
|
27.1 Units on a scale
Standard Deviation 14.04
|
25.5 Units on a scale
Standard Deviation 12.93
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 48
|
25.3 Units on a scale
Standard Deviation 11.67
|
26.5 Units on a scale
Standard Deviation 14.29
|
26.7 Units on a scale
Standard Deviation 13.03
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 52
|
26.3 Units on a scale
Standard Deviation 12.89
|
27.0 Units on a scale
Standard Deviation 12.25
|
25.3 Units on a scale
Standard Deviation 11.87
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Baseline
|
42.9 Units on a scale
Standard Deviation 26.41
|
37.2 Units on a scale
Standard Deviation 23.40
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 4
|
46.9 Units on a scale
Standard Deviation 27.17
|
36.5 Units on a scale
Standard Deviation 21.43
|
41.2 Units on a scale
Standard Deviation 25.74
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 8
|
47.2 Units on a scale
Standard Deviation 26.25
|
36.8 Units on a scale
Standard Deviation 22.99
|
46.8 Units on a scale
Standard Deviation 28.77
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 12
|
45.6 Units on a scale
Standard Deviation 27.93
|
34.7 Units on a scale
Standard Deviation 21.12
|
40.0 Units on a scale
Standard Deviation 23.83
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 16
|
43.3 Units on a scale
Standard Deviation 24.96
|
35.0 Units on a scale
Standard Deviation 20.15
|
44.8 Units on a scale
Standard Deviation 28.22
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 20
|
41.9 Units on a scale
Standard Deviation 27.50
|
30.5 Units on a scale
Standard Deviation 17.46
|
38.2 Units on a scale
Standard Deviation 26.01
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 24
|
50.3 Units on a scale
Standard Deviation 27.74
|
39.6 Units on a scale
Standard Deviation 24.13
|
32.9 Units on a scale
Standard Deviation 20.16
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 28
|
45.6 Units on a scale
Standard Deviation 28.95
|
31.8 Units on a scale
Standard Deviation 21.28
|
32.9 Units on a scale
Standard Deviation 21.64
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 32
|
42.4 Units on a scale
Standard Deviation 24.50
|
39.1 Units on a scale
Standard Deviation 22.55
|
24.6 Units on a scale
Standard Deviation 16.64
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 36
|
37.6 Units on a scale
Standard Deviation 21.07
|
31.8 Units on a scale
Standard Deviation 18.79
|
40.0 Units on a scale
Standard Deviation 25.82
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 40
|
44.1 Units on a scale
Standard Deviation 26.87
|
37.4 Units on a scale
Standard Deviation 21.52
|
32.5 Units on a scale
Standard Deviation 14.88
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 44
|
36.7 Units on a scale
Standard Deviation 24.97
|
34.1 Units on a scale
Standard Deviation 19.70
|
34.5 Units on a scale
Standard Deviation 20.18
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 48
|
44.0 Units on a scale
Standard Deviation 22.53
|
37.2 Units on a scale
Standard Deviation 23.74
|
38.3 Units on a scale
Standard Deviation 21.67
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Snoring Score: Week 52
|
45.6 Units on a scale
Standard Deviation 23.41
|
37.2 Units on a scale
Standard Deviation 22.07
|
37.3 Units on a scale
Standard Deviation 19.81
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Baseline
|
38.3 Units on a scale
Standard Deviation 18.74
|
34.8 Units on a scale
Standard Deviation 17.51
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 4
|
33.7 Units on a scale
Standard Deviation 15.01
|
32.2 Units on a scale
Standard Deviation 14.92
|
41.6 Units on a scale
Standard Deviation 19.69
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 16
|
38.6 Units on a scale
Standard Deviation 19.44
|
30.8 Units on a scale
Standard Deviation 15.43
|
40.8 Units on a scale
Standard Deviation 16.03
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 20
|
38.7 Units on a scale
Standard Deviation 22.89
|
32.1 Units on a scale
Standard Deviation 13.85
|
36.0 Units on a scale
Standard Deviation 11.92
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 24
|
32.2 Units on a scale
Standard Deviation 19.95
|
36.3 Units on a scale
Standard Deviation 18.02
|
35.8 Units on a scale
Standard Deviation 13.29
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 32
|
34.2 Units on a scale
Standard Deviation 20.09
|
32.0 Units on a scale
Standard Deviation 14.20
|
33.6 Units on a scale
Standard Deviation 10.53
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 40
|
34.7 Units on a scale
Standard Deviation 18.96
|
33.0 Units on a scale
Standard Deviation 16.83
|
33.9 Units on a scale
Standard Deviation 16.91
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 44
|
32.9 Units on a scale
Standard Deviation 23.13
|
38.9 Units on a scale
Standard Deviation 16.87
|
43.3 Units on a scale
Standard Deviation 19.70
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 48
|
36.3 Units on a scale
Standard Deviation 18.59
|
32.1 Units on a scale
Standard Deviation 16.29
|
34.9 Units on a scale
Standard Deviation 18.61
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 52
|
35.9 Units on a scale
Standard Deviation 19.59
|
32.9 Units on a scale
Standard Deviation 17.59
|
28.1 Units on a scale
Standard Deviation 9.24
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 4
|
70.6 Units on a scale
Standard Deviation 20.15
|
71.6 Units on a scale
Standard Deviation 18.80
|
68.4 Units on a scale
Standard Deviation 19.53
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 8
|
72.5 Units on a scale
Standard Deviation 16.45
|
72.6 Units on a scale
Standard Deviation 20.58
|
66.1 Units on a scale
Standard Deviation 24.11
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 16
|
73.3 Units on a scale
Standard Deviation 20.20
|
69.0 Units on a scale
Standard Deviation 18.71
|
71.4 Units on a scale
Standard Deviation 16.52
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 20
|
70.5 Units on a scale
Standard Deviation 21.56
|
67.6 Units on a scale
Standard Deviation 17.86
|
75.5 Units on a scale
Standard Deviation 16.35
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 24
|
71.6 Units on a scale
Standard Deviation 21.02
|
67.4 Units on a scale
Standard Deviation 20.59
|
70.7 Units on a scale
Standard Deviation 18.17
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 28
|
71.7 Units on a scale
Standard Deviation 22.03
|
71.2 Units on a scale
Standard Deviation 21.47
|
64.3 Units on a scale
Standard Deviation 19.89
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 32
|
74.7 Units on a scale
Standard Deviation 21.21
|
72.4 Units on a scale
Standard Deviation 19.67
|
64.6 Units on a scale
Standard Deviation 23.67
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 36
|
74.1 Units on a scale
Standard Deviation 22.38
|
68.8 Units on a scale
Standard Deviation 15.76
|
62.9 Units on a scale
Standard Deviation 25.63
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 40
|
68.5 Units on a scale
Standard Deviation 21.34
|
69.1 Units on a scale
Standard Deviation 18.51
|
67.5 Units on a scale
Standard Deviation 23.15
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 44
|
72.2 Units on a scale
Standard Deviation 22.90
|
70.0 Units on a scale
Standard Deviation 21.79
|
60.9 Units on a scale
Standard Deviation 21.19
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 48
|
73.0 Units on a scale
Standard Deviation 18.96
|
70.2 Units on a scale
Standard Deviation 19.70
|
65.8 Units on a scale
Standard Deviation 19.75
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 52
|
70.0 Units on a scale
Standard Deviation 20.48
|
68.6 Units on a scale
Standard Deviation 22.74
|
68.0 Units on a scale
Standard Deviation 18.97
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Baseline
|
40.3 Units on a scale
Standard Deviation 17.05
|
41.8 Units on a scale
Standard Deviation 18.51
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 4
|
39.6 Units on a scale
Standard Deviation 15.23
|
42.4 Units on a scale
Standard Deviation 18.13
|
44.8 Units on a scale
Standard Deviation 20.87
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 8
|
36.5 Units on a scale
Standard Deviation 10.75
|
40.1 Units on a scale
Standard Deviation 18.78
|
46.7 Units on a scale
Standard Deviation 21.81
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 12
|
41.7 Units on a scale
Standard Deviation 18.86
|
40.4 Units on a scale
Standard Deviation 18.48
|
43.8 Units on a scale
Standard Deviation 21.15
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 16
|
37.1 Units on a scale
Standard Deviation 16.00
|
39.1 Units on a scale
Standard Deviation 17.06
|
47.0 Units on a scale
Standard Deviation 18.07
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 20
|
41.3 Units on a scale
Standard Deviation 19.62
|
37.5 Units on a scale
Standard Deviation 17.82
|
40.0 Units on a scale
Standard Deviation 18.14
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 24
|
39.5 Units on a scale
Standard Deviation 17.02
|
43.4 Units on a scale
Standard Deviation 18.06
|
39.0 Units on a scale
Standard Deviation 16.71
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 36
|
34.9 Units on a scale
Standard Deviation 17.41
|
39.2 Units on a scale
Standard Deviation 14.70
|
45.7 Units on a scale
Standard Deviation 24.77
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 40
|
38.6 Units on a scale
Standard Deviation 17.96
|
43.3 Units on a scale
Standard Deviation 14.70
|
41.7 Units on a scale
Standard Deviation 25.88
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 44
|
39.3 Units on a scale
Standard Deviation 17.84
|
44.3 Units on a scale
Standard Deviation 16.99
|
50.3 Units on a scale
Standard Deviation 26.89
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 52
|
39.0 Units on a scale
Standard Deviation 16.60
|
40.0 Units on a scale
Standard Deviation 14.47
|
44.4 Units on a scale
Standard Deviation 20.57
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Baseline
|
33.4 Units on a scale
Standard Deviation 12.63
|
33.2 Units on a scale
Standard Deviation 14.19
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 4
|
31.4 Units on a scale
Standard Deviation 13.22
|
31.6 Units on a scale
Standard Deviation 11.53
|
35.6 Units on a scale
Standard Deviation 13.51
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 8
|
29.6 Units on a scale
Standard Deviation 10.77
|
31.5 Units on a scale
Standard Deviation 13.98
|
36.1 Units on a scale
Standard Deviation 16.52
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 16
|
32.1 Units on a scale
Standard Deviation 14.44
|
31.8 Units on a scale
Standard Deviation 12.14
|
34.0 Units on a scale
Standard Deviation 9.92
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 32
|
33.5 Units on a scale
Standard Deviation 14.89
|
31.6 Units on a scale
Standard Deviation 11.07
|
36.3 Units on a scale
Standard Deviation 12.86
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 36
|
33.5 Units on a scale
Standard Deviation 19.04
|
32.2 Units on a scale
Standard Deviation 12.20
|
40.7 Units on a scale
Standard Deviation 14.56
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 20
|
34.0 Units on a scale
Standard Deviation 16.21
|
32.9 Units on a scale
Standard Deviation 13.01
|
29.7 Units on a scale
Standard Deviation 7.67
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 24
|
30.9 Units on a scale
Standard Deviation 14.92
|
34.6 Units on a scale
Standard Deviation 13.63
|
30.7 Units on a scale
Standard Deviation 9.71
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 28
|
34.4 Units on a scale
Standard Deviation 18.22
|
32.9 Units on a scale
Standard Deviation 13.74
|
37.9 Units on a scale
Standard Deviation 13.18
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 36
|
31.4 Units on a scale
Standard Deviation 18.11
|
31.6 Units on a scale
Standard Deviation 12.86
|
35.2 Units on a scale
Standard Deviation 12.00
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 48
|
33.3 Units on a scale
Standard Deviation 15.06
|
32.0 Units on a scale
Standard Deviation 12.20
|
34.4 Units on a scale
Standard Deviation 11.66
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 52
|
32.4 Units on a scale
Standard Deviation 13.92
|
32.6 Units on a scale
Standard Deviation 14.08
|
31.6 Units on a scale
Standard Deviation 9.91
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Baseline
|
35.5 Units on a scale
Standard Deviation 13.20
|
34.4 Units on a scale
Standard Deviation 14.17
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 8
|
31.4 Units on a scale
Standard Deviation 10.70
|
33.1 Units on a scale
Standard Deviation 13.16
|
38.5 Units on a scale
Standard Deviation 17.14
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 12
|
33.2 Units on a scale
Standard Deviation 14.40
|
33.2 Units on a scale
Standard Deviation 13.21
|
36.4 Units on a scale
Standard Deviation 13.26
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 16
|
33.9 Units on a scale
Standard Deviation 15.58
|
32.0 Units on a scale
Standard Deviation 11.95
|
36.8 Units on a scale
Standard Deviation 11.34
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 44
|
33.0 Units on a scale
Standard Deviation 18.97
|
36.9 Units on a scale
Standard Deviation 13.73
|
41.7 Units on a scale
Standard Deviation 15.83
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 24
|
8.0 Units on a scale
Standard Deviation 4.21
|
8.0 Units on a scale
Standard Deviation 4.33
|
8.3 Units on a scale
Standard Deviation 2.13
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 28
|
8.4 Units on a scale
Standard Deviation 5.20
|
7.2 Units on a scale
Standard Deviation 1.38
|
7.9 Units on a scale
Standard Deviation 2.98
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 40
|
8.1 Units on a scale
Standard Deviation 4.39
|
8.1 Units on a scale
Standard Deviation 3.92
|
10.0 Units on a scale
Standard Deviation 6.23
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 12
|
35.1 Units on a scale
Standard Deviation 16.20
|
32.8 Units on a scale
Standard Deviation 16.90
|
38.8 Units on a scale
Standard Deviation 15.51
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 28
|
39.3 Units on a scale
Standard Deviation 22.69
|
37.2 Units on a scale
Standard Deviation 16.40
|
38.5 Units on a scale
Standard Deviation 13.20
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Disturbance Score: Week 36
|
38.2 Units on a scale
Standard Deviation 23.61
|
32.2 Units on a scale
Standard Deviation 16.82
|
45.9 Units on a scale
Standard Deviation 21.67
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Baseline
|
8.3 Units on a scale
Standard Deviation 3.79
|
7.5 Units on a scale
Standard Deviation 2.42
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 4
|
8.9 Units on a scale
Standard Deviation 4.55
|
8.1 Units on a scale
Standard Deviation 3.32
|
6.9 Units on a scale
Standard Deviation 1.92
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 8
|
8.1 Units on a scale
Standard Deviation 3.31
|
7.8 Units on a scale
Standard Deviation 3.72
|
7.9 Units on a scale
Standard Deviation 3.19
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 12
|
8.8 Units on a scale
Standard Deviation 4.46
|
7.5 Units on a scale
Standard Deviation 3.18
|
7.7 Units on a scale
Standard Deviation 2.89
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Baseline
|
68.6 Units on a scale
Standard Deviation 18.25
|
69.1 Units on a scale
Standard Deviation 21.69
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Adequacy Score: Week 12
|
71.9 Units on a scale
Standard Deviation 22.92
|
68.2 Units on a scale
Standard Deviation 21.47
|
70.9 Units on a scale
Standard Deviation 20.69
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 28
|
44.4 Units on a scale
Standard Deviation 21.57
|
41.2 Units on a scale
Standard Deviation 19.33
|
46.7 Units on a scale
Standard Deviation 17.15
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 32
|
43.7 Units on a scale
Standard Deviation 21.16
|
41.5 Units on a scale
Standard Deviation 15.63
|
48.2 Units on a scale
Standard Deviation 17.46
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Somnolence Score: Week 48
|
41.3 Units on a scale
Standard Deviation 15.40
|
42.3 Units on a scale
Standard Deviation 13.48
|
46.1 Units on a scale
Standard Deviation 23.52
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Quantity Hours Slept Score: Week 44
|
7.1 Units on a scale
Standard Deviation 2.04
|
6.7 Units on a scale
Standard Deviation 0.99
|
8.7 Units on a scale
Standard Deviation 5.44
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 20
|
0.7 Units on a scale
Standard Deviation 0.46
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.6 Units on a scale
Standard Deviation 0.50
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 24
|
0.4 Units on a scale
Standard Deviation 0.50
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.5 Units on a scale
Standard Deviation 0.52
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 28
|
0.4 Units on a scale
Standard Deviation 0.51
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.6 Units on a scale
Standard Deviation 0.51
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 32
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.6 Units on a scale
Standard Deviation 0.50
|
0.3 Units on a scale
Standard Deviation 0.48
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 44
|
0.6 Units on a scale
Standard Deviation 0.51
|
0.7 Units on a scale
Standard Deviation 0.47
|
0.2 Units on a scale
Standard Deviation 0.40
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Optimal Hours Slept Score: Week 48
|
0.6 Units on a scale
Standard Deviation 0.50
|
0.4 Units on a scale
Standard Deviation 0.50
|
0.3 Units on a scale
Standard Deviation 0.49
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 12
|
32.2 Units on a scale
Standard Deviation 14.36
|
33.3 Units on a scale
Standard Deviation 12.89
|
34.1 Units on a scale
Standard Deviation 13.03
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 32
|
31.7 Units on a scale
Standard Deviation 14.10
|
30.5 Units on a scale
Standard Deviation 11.72
|
35.1 Units on a scale
Standard Deviation 13.92
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 40
|
33.0 Units on a scale
Standard Deviation 15.07
|
33.7 Units on a scale
Standard Deviation 13.55
|
34.6 Units on a scale
Standard Deviation 17.27
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index I Score: Week 44
|
32.4 Units on a scale
Standard Deviation 18.32
|
33.5 Units on a scale
Standard Deviation 13.25
|
38.5 Units on a scale
Standard Deviation 14.86
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 4
|
32.6 Units on a scale
Standard Deviation 11.70
|
32.1 Units on a scale
Standard Deviation 11.57
|
38.2 Units on a scale
Standard Deviation 14.53
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 20
|
35.9 Units on a scale
Standard Deviation 17.75
|
33.1 Units on a scale
Standard Deviation 11.87
|
32.0 Units on a scale
Standard Deviation 8.63
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 24
|
32.1 Units on a scale
Standard Deviation 15.49
|
35.9 Units on a scale
Standard Deviation 13.54
|
33.8 Units on a scale
Standard Deviation 11.25
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 28
|
36.7 Units on a scale
Standard Deviation 18.79
|
35.0 Units on a scale
Standard Deviation 13.07
|
38.8 Units on a scale
Standard Deviation 11.64
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 40
|
33.7 Units on a scale
Standard Deviation 15.62
|
33.9 Units on a scale
Standard Deviation 12.86
|
34.8 Units on a scale
Standard Deviation 16.31
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 48
|
33.7 Units on a scale
Standard Deviation 15.44
|
32.9 Units on a scale
Standard Deviation 12.13
|
36.8 Units on a scale
Standard Deviation 13.82
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Sleep Problems Index II Score: Week 52
|
33.8 Units on a scale
Standard Deviation 14.86
|
33.0 Units on a scale
Standard Deviation 13.66
|
32.2 Units on a scale
Standard Deviation 10.53
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Short of Breath or Headache score: Week 20
|
24.8 Units on a scale
Standard Deviation 10.78
|
29.5 Units on a scale
Standard Deviation 18.57
|
23.6 Units on a scale
Standard Deviation 12.06
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Outcome measures
| Measure |
Vehicle QD
n=43 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=44 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Quantity Hours Slept Score: Week 4
|
8.2 Units on a scale
Standard Deviation 3.88
|
7.3 Units on a scale
Standard Deviation 1.55
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Quantity Hours Slept Score: Week 8
|
8.3 Units on a scale
Standard Deviation 3.45
|
6.9 Units on a scale
Standard Deviation 1.68
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Optimal Hours Slept Score: Week 8
|
0.5 Units on a scale
Standard Deviation 0.52
|
0.5 Units on a scale
Standard Deviation 0.52
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Short of Breath or Headache score: Week 4
|
26.7 Units on a scale
Standard Deviation 13.17
|
27.5 Units on a scale
Standard Deviation 14.22
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Snoring Score: Week 8
|
44.6 Units on a scale
Standard Deviation 24.70
|
38.7 Units on a scale
Standard Deviation 23.26
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Disturbance Score: Week 4
|
38.3 Units on a scale
Standard Deviation 18.36
|
38.6 Units on a scale
Standard Deviation 18.61
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Disturbance Score: Week 8
|
33.6 Units on a scale
Standard Deviation 12.81
|
41.4 Units on a scale
Standard Deviation 16.77
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Disturbance Score: Week 12
|
43.3 Units on a scale
Standard Deviation 16.65
|
43.6 Units on a scale
Standard Deviation 13.02
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Adequacy Score: Week 0
|
67.0 Units on a scale
Standard Deviation 20.99
|
66.1 Units on a scale
Standard Deviation 20.71
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Somnolence Score: Week 0
|
44.8 Units on a scale
Standard Deviation 20.74
|
45.9 Units on a scale
Standard Deviation 19.30
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Somnolence Score: Week 12
|
33.3 Units on a scale
Standard Deviation 13.33
|
50.5 Units on a scale
Standard Deviation 19.57
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Problems Index I Score: Week 8
|
32.8 Units on a scale
Standard Deviation 9.51
|
38.9 Units on a scale
Standard Deviation 13.07
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Problems Index II Score: Week 4
|
35.8 Units on a scale
Standard Deviation 16.81
|
38.0 Units on a scale
Standard Deviation 16.06
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Problems Index II Score: Week 8
|
34.6 Units on a scale
Standard Deviation 10.26
|
41.4 Units on a scale
Standard Deviation 13.30
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Problems Index II Score: Week 12
|
34.1 Units on a scale
Standard Deviation 12.97
|
40.3 Units on a scale
Standard Deviation 6.13
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Somnolence Score: Week 4
|
42.9 Units on a scale
Standard Deviation 22.76
|
48.3 Units on a scale
Standard Deviation 19.49
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Somnolence Score: Week 8
|
45.6 Units on a scale
Standard Deviation 22.91
|
54.2 Units on a scale
Standard Deviation 19.17
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Quantity Hours Slept Score: Week 0
|
7.3 Units on a scale
Standard Deviation 2.28
|
7.6 Units on a scale
Standard Deviation 3.56
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Quantity Hours Slept Score: Week 12
|
8.0 Units on a scale
Standard Deviation 1.00
|
7.3 Units on a scale
Standard Deviation 1.70
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Optimal Hours Slept Score: Week 0
|
0.6 Units on a scale
Standard Deviation 0.49
|
0.4 Units on a scale
Standard Deviation 0.50
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Optimal Hours Slept Score: Week 4
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.6 Units on a scale
Standard Deviation 0.50
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Optimal Hours Slept Score: Week 12
|
0.7 Units on a scale
Standard Deviation 0.58
|
0.4 Units on a scale
Standard Deviation 0.53
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Short of Breath or Headache score: Week 0
|
27.9 Units on a scale
Standard Deviation 16.98
|
28.6 Units on a scale
Standard Deviation 17.47
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Short of Breath or Headache score: Week 8
|
27.7 Units on a scale
Standard Deviation 15.36
|
33.3 Units on a scale
Standard Deviation 19.52
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Short of Breath or Headache score: Week 12
|
20.0 Units on a scale
Standard Deviation 0.00
|
22.9 Units on a scale
Standard Deviation 7.56
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Snoring Score: Week 0
|
43.3 Units on a scale
Standard Deviation 28.26
|
37.7 Units on a scale
Standard Deviation 24.86
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Snoring Score: Week 4
|
45.7 Units on a scale
Standard Deviation 28.39
|
39.2 Units on a scale
Standard Deviation 27.96
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Snoring Score: Week 12
|
53.3 Units on a scale
Standard Deviation 23.09
|
34.3 Units on a scale
Standard Deviation 19.02
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Disturbance Score: Week 0
|
41.0 Units on a scale
Standard Deviation 19.08
|
40.9 Units on a scale
Standard Deviation 19.39
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Adequacy Score: Week 4
|
71.0 Units on a scale
Standard Deviation 23.00
|
67.1 Units on a scale
Standard Deviation 24.22
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Adequacy Score: Week 8
|
70.0 Units on a scale
Standard Deviation 22.36
|
66.0 Units on a scale
Standard Deviation 19.20
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Adequacy Score: Week 12
|
76.7 Units on a scale
Standard Deviation 15.28
|
64.3 Units on a scale
Standard Deviation 17.18
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Problems Index I Score: Week 0
|
36.3 Units on a scale
Standard Deviation 13.53
|
37.3 Units on a scale
Standard Deviation 15.29
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Problems Index I Score: Week 4
|
32.9 Units on a scale
Standard Deviation 16.27
|
36.7 Units on a scale
Standard Deviation 16.33
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Problems Index I Score: Week 12
|
31.1 Units on a scale
Standard Deviation 11.71
|
39.0 Units on a scale
Standard Deviation 5.35
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Sleep Problems Index II Score: Week 0
|
38.4 Units on a scale
Standard Deviation 14.19
|
38.6 Units on a scale
Standard Deviation 15.55
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Outcome measures
| Measure |
Vehicle QD
n=69 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=78 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 8
|
8.5 Units on a scale
Standard Deviation 3.77
|
7.9 Units on a scale
Standard Deviation 3.92
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 16
|
8.5 Units on a scale
Standard Deviation 4.11
|
8.5 Units on a scale
Standard Deviation 4.90
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 20
|
7.0 Units on a scale
Standard Deviation 1.20
|
7.7 Units on a scale
Standard Deviation 1.55
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 48
|
7.2 Units on a scale
Standard Deviation 1.63
|
7.2 Units on a scale
Standard Deviation 1.46
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 52
|
8.0 Units on a scale
Standard Deviation 4.57
|
7.0 Units on a scale
Standard Deviation 1.24
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Baseline
|
0.5 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.50
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 4
|
0.6 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.50
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 8
|
0.7 Units on a scale
Standard Deviation 0.46
|
0.6 Units on a scale
Standard Deviation 0.49
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 12
|
0.4 Units on a scale
Standard Deviation 0.50
|
0.6 Units on a scale
Standard Deviation 0.50
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 20
|
0.6 Units on a scale
Standard Deviation 0.52
|
0.5 Units on a scale
Standard Deviation 0.52
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 24
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.6 Units on a scale
Standard Deviation 0.50
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 40
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.5 Units on a scale
Standard Deviation 0.51
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 44
|
0.6 Units on a scale
Standard Deviation 0.53
|
0.9 Units on a scale
Standard Deviation 0.33
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Baseline
|
24.1 Units on a scale
Standard Deviation 9.44
|
27.2 Units on a scale
Standard Deviation 15.45
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 12
|
23.0 Units on a scale
Standard Deviation 7.33
|
26.0 Units on a scale
Standard Deviation 12.97
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 16
|
24.2 Units on a scale
Standard Deviation 8.38
|
24.9 Units on a scale
Standard Deviation 10.96
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 20
|
22.5 Units on a scale
Standard Deviation 7.07
|
29.2 Units on a scale
Standard Deviation 17.54
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 12
|
49.0 Units on a scale
Standard Deviation 28.64
|
33.5 Units on a scale
Standard Deviation 20.95
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 28
|
48.6 Units on a scale
Standard Deviation 30.24
|
22.2 Units on a scale
Standard Deviation 6.67
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 32
|
40.0 Units on a scale
Standard Deviation 19.32
|
37.8 Units on a scale
Standard Deviation 21.72
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 40
|
44.7 Units on a scale
Standard Deviation 26.01
|
38.5 Units on a scale
Standard Deviation 21.85
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 52
|
46.7 Units on a scale
Standard Deviation 20.93
|
41.7 Units on a scale
Standard Deviation 21.67
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Baseline
|
38.3 Units on a scale
Standard Deviation 18.74
|
34.8 Units on a scale
Standard Deviation 17.51
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 12
|
33.3 Units on a scale
Standard Deviation 14.51
|
32.3 Units on a scale
Standard Deviation 17.12
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 28
|
37.3 Units on a scale
Standard Deviation 11.78
|
31.1 Units on a scale
Standard Deviation 12.43
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 36
|
27.7 Units on a scale
Standard Deviation 9.43
|
27.7 Units on a scale
Standard Deviation 10.93
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 40
|
34.3 Units on a scale
Standard Deviation 14.80
|
33.2 Units on a scale
Standard Deviation 18.06
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 48
|
33.9 Units on a scale
Standard Deviation 11.81
|
30.2 Units on a scale
Standard Deviation 16.76
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 8
|
72.8 Units on a scale
Standard Deviation 17.20
|
73.2 Units on a scale
Standard Deviation 21.43
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 4
|
40.0 Units on a scale
Standard Deviation 15.56
|
42.4 Units on a scale
Standard Deviation 18.13
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 20
|
32.5 Units on a scale
Standard Deviation 12.05
|
31.8 Units on a scale
Standard Deviation 14.12
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 24
|
28.0 Units on a scale
Standard Deviation 12.25
|
34.4 Units on a scale
Standard Deviation 14.87
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 40
|
30.8 Units on a scale
Standard Deviation 11.15
|
34.4 Units on a scale
Standard Deviation 14.78
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 24
|
29.6 Units on a scale
Standard Deviation 11.67
|
35.4 Units on a scale
Standard Deviation 14.29
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 28
|
36.9 Units on a scale
Standard Deviation 12.41
|
30.9 Units on a scale
Standard Deviation 11.08
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 32
|
30.9 Units on a scale
Standard Deviation 8.47
|
31.5 Units on a scale
Standard Deviation 11.36
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 48
|
31.4 Units on a scale
Standard Deviation 9.57
|
31.6 Units on a scale
Standard Deviation 12.65
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 24
|
39.6 Units on a scale
Standard Deviation 16.07
|
42.8 Units on a scale
Standard Deviation 19.98
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 28
|
48.6 Units on a scale
Standard Deviation 24.26
|
37.0 Units on a scale
Standard Deviation 20.03
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 32
|
44.6 Units on a scale
Standard Deviation 20.76
|
42.5 Units on a scale
Standard Deviation 15.04
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 36
|
35.6 Units on a scale
Standard Deviation 19.63
|
31.4 Units on a scale
Standard Deviation 9.20
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 40
|
36.1 Units on a scale
Standard Deviation 16.51
|
43.1 Units on a scale
Standard Deviation 15.35
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 44
|
37.1 Units on a scale
Standard Deviation 16.71
|
40.7 Units on a scale
Standard Deviation 18.99
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 48
|
39.6 Units on a scale
Standard Deviation 14.62
|
43.1 Units on a scale
Standard Deviation 13.04
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 52
|
38.7 Units on a scale
Standard Deviation 13.14
|
39.1 Units on a scale
Standard Deviation 14.11
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Baseline
|
33.4 Units on a scale
Standard Deviation 12.63
|
33.2 Units on a scale
Standard Deviation 14.19
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 4
|
31.4 Units on a scale
Standard Deviation 13.64
|
31.6 Units on a scale
Standard Deviation 11.53
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 8
|
28.9 Units on a scale
Standard Deviation 10.79
|
30.7 Units on a scale
Standard Deviation 13.99
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 12
|
29.3 Units on a scale
Standard Deviation 13.27
|
33.2 Units on a scale
Standard Deviation 13.22
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 16
|
30.2 Units on a scale
Standard Deviation 11.78
|
32.6 Units on a scale
Standard Deviation 12.10
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 28
|
35.7 Units on a scale
Standard Deviation 13.97
|
28.5 Units on a scale
Standard Deviation 13.34
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 32
|
29.2 Units on a scale
Standard Deviation 8.39
|
30.5 Units on a scale
Standard Deviation 12.63
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 36
|
28.3 Units on a scale
Standard Deviation 9.83
|
26.2 Units on a scale
Standard Deviation 11.45
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 44
|
29.5 Units on a scale
Standard Deviation 11.93
|
30.7 Units on a scale
Standard Deviation 14.32
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 48
|
31.6 Units on a scale
Standard Deviation 10.74
|
31.0 Units on a scale
Standard Deviation 12.83
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index I Score: Week 52
|
30.2 Units on a scale
Standard Deviation 9.13
|
32.0 Units on a scale
Standard Deviation 13.62
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Baseline
|
35.5 Units on a scale
Standard Deviation 13.20
|
34.4 Units on a scale
Standard Deviation 14.17
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 4
|
32.8 Units on a scale
Standard Deviation 12.00
|
32.1 Units on a scale
Standard Deviation 11.57
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 8
|
30.3 Units on a scale
Standard Deviation 10.27
|
32.4 Units on a scale
Standard Deviation 13.36
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 12
|
30.5 Units on a scale
Standard Deviation 12.70
|
32.8 Units on a scale
Standard Deviation 13.47
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 16
|
31.2 Units on a scale
Standard Deviation 12.90
|
32.7 Units on a scale
Standard Deviation 11.83
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 20
|
33.2 Units on a scale
Standard Deviation 12.21
|
31.1 Units on a scale
Standard Deviation 11.85
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 36
|
27.9 Units on a scale
Standard Deviation 8.99
|
27.5 Units on a scale
Standard Deviation 8.80
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 40
|
31.3 Units on a scale
Standard Deviation 10.00
|
34.3 Units on a scale
Standard Deviation 14.03
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 44
|
28.1 Units on a scale
Standard Deviation 9.82
|
33.8 Units on a scale
Standard Deviation 14.04
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Problems Index II Score: Week 52
|
30.6 Units on a scale
Standard Deviation 8.85
|
32.4 Units on a scale
Standard Deviation 12.20
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Baseline
|
8.3 Units on a scale
Standard Deviation 3.79
|
7.5 Units on a scale
Standard Deviation 2.42
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 4
|
9.0 Units on a scale
Standard Deviation 4.68
|
8.1 Units on a scale
Standard Deviation 3.32
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 12
|
8.6 Units on a scale
Standard Deviation 4.15
|
7.6 Units on a scale
Standard Deviation 3.22
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 24
|
7.2 Units on a scale
Standard Deviation 1.99
|
7.4 Units on a scale
Standard Deviation 3.45
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 28
|
6.9 Units on a scale
Standard Deviation 1.07
|
7.4 Units on a scale
Standard Deviation 1.51
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 32
|
8.5 Units on a scale
Standard Deviation 4.24
|
7.6 Units on a scale
Standard Deviation 1.22
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 36
|
7.0 Units on a scale
Standard Deviation 0.89
|
8.0 Units on a scale
Standard Deviation 1.41
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 40
|
8.3 Units on a scale
Standard Deviation 4.57
|
7.5 Units on a scale
Standard Deviation 2.97
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Quantity Hours Slept Score: Week 44
|
6.7 Units on a scale
Standard Deviation 1.11
|
7.1 Units on a scale
Standard Deviation 0.60
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 16
|
0.5 Units on a scale
Standard Deviation 0.51
|
0.6 Units on a scale
Standard Deviation 0.50
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 28
|
0.7 Units on a scale
Standard Deviation 0.49
|
0.6 Units on a scale
Standard Deviation 0.53
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 32
|
0.6 Units on a scale
Standard Deviation 0.50
|
0.7 Units on a scale
Standard Deviation 0.45
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 36
|
0.7 Units on a scale
Standard Deviation 0.52
|
0.9 Units on a scale
Standard Deviation 0.38
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 48
|
0.6 Units on a scale
Standard Deviation 0.51
|
0.4 Units on a scale
Standard Deviation 0.50
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Optimal Hours Slept Score: Week 52
|
0.4 Units on a scale
Standard Deviation 0.51
|
0.5 Units on a scale
Standard Deviation 0.51
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 4
|
24.0 Units on a scale
Standard Deviation 12.21
|
23.9 Units on a scale
Standard Deviation 9.81
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 8
|
24.8 Units on a scale
Standard Deviation 10.46
|
23.6 Units on a scale
Standard Deviation 9.90
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 24
|
24.7 Units on a scale
Standard Deviation 11.25
|
26.5 Units on a scale
Standard Deviation 11.99
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 28
|
31.4 Units on a scale
Standard Deviation 22.68
|
26.7 Units on a scale
Standard Deviation 14.14
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 32
|
25.0 Units on a scale
Standard Deviation 8.94
|
22.2 Units on a scale
Standard Deviation 8.47
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 36
|
20.0 Units on a scale
Standard Deviation 0.00
|
20.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 40
|
22.4 Units on a scale
Standard Deviation 6.64
|
25.4 Units on a scale
Standard Deviation 12.08
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 44
|
22.9 Units on a scale
Standard Deviation 7.56
|
28.9 Units on a scale
Standard Deviation 14.53
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 48
|
22.4 Units on a scale
Standard Deviation 6.64
|
25.0 Units on a scale
Standard Deviation 12.16
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Short of Breath or Headache score: Week 52
|
22.7 Units on a scale
Standard Deviation 7.04
|
27.8 Units on a scale
Standard Deviation 11.66
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Baseline
|
42.9 Units on a scale
Standard Deviation 26.41
|
37.2 Units on a scale
Standard Deviation 23.40
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 4
|
47.3 Units on a scale
Standard Deviation 27.53
|
36.5 Units on a scale
Standard Deviation 21.43
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 8
|
49.6 Units on a scale
Standard Deviation 26.53
|
35.5 Units on a scale
Standard Deviation 22.77
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 16
|
45.3 Units on a scale
Standard Deviation 27.36
|
34.6 Units on a scale
Standard Deviation 19.80
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 20
|
42.5 Units on a scale
Standard Deviation 27.12
|
23.1 Units on a scale
Standard Deviation 7.51
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 24
|
54.1 Units on a scale
Standard Deviation 26.23
|
38.1 Units on a scale
Standard Deviation 22.72
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 36
|
36.7 Units on a scale
Standard Deviation 15.06
|
25.7 Units on a scale
Standard Deviation 9.76
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 44
|
28.6 Units on a scale
Standard Deviation 10.69
|
28.9 Units on a scale
Standard Deviation 14.53
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Snoring Score: Week 48
|
44.7 Units on a scale
Standard Deviation 16.63
|
40.0 Units on a scale
Standard Deviation 24.32
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 4
|
34.3 Units on a scale
Standard Deviation 15.11
|
32.2 Units on a scale
Standard Deviation 14.92
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 8
|
31.7 Units on a scale
Standard Deviation 12.00
|
35.1 Units on a scale
Standard Deviation 16.27
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 16
|
35.9 Units on a scale
Standard Deviation 17.17
|
30.6 Units on a scale
Standard Deviation 14.57
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 20
|
32.8 Units on a scale
Standard Deviation 12.22
|
28.0 Units on a scale
Standard Deviation 9.31
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 24
|
30.7 Units on a scale
Standard Deviation 15.90
|
35.9 Units on a scale
Standard Deviation 18.34
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 32
|
31.4 Units on a scale
Standard Deviation 14.75
|
32.3 Units on a scale
Standard Deviation 12.28
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 44
|
23.9 Units on a scale
Standard Deviation 10.47
|
34.3 Units on a scale
Standard Deviation 16.25
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Disturbance Score: Week 52
|
32.4 Units on a scale
Standard Deviation 16.27
|
31.6 Units on a scale
Standard Deviation 15.29
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Baseline
|
68.6 Units on a scale
Standard Deviation 18.25
|
69.1 Units on a scale
Standard Deviation 21.69
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 4
|
71.0 Units on a scale
Standard Deviation 20.74
|
71.6 Units on a scale
Standard Deviation 18.80
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 12
|
75.0 Units on a scale
Standard Deviation 20.90
|
68.0 Units on a scale
Standard Deviation 21.74
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 16
|
74.7 Units on a scale
Standard Deviation 20.65
|
66.5 Units on a scale
Standard Deviation 17.98
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 20
|
70.0 Units on a scale
Standard Deviation 22.68
|
66.9 Units on a scale
Standard Deviation 21.36
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 24
|
76.5 Units on a scale
Standard Deviation 16.18
|
68.1 Units on a scale
Standard Deviation 20.88
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 28
|
70.0 Units on a scale
Standard Deviation 19.15
|
72.2 Units on a scale
Standard Deviation 28.19
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 32
|
78.8 Units on a scale
Standard Deviation 14.55
|
74.4 Units on a scale
Standard Deviation 19.87
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 36
|
75.0 Units on a scale
Standard Deviation 15.17
|
72.9 Units on a scale
Standard Deviation 17.99
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 40
|
72.9 Units on a scale
Standard Deviation 16.11
|
68.1 Units on a scale
Standard Deviation 18.33
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 44
|
67.1 Units on a scale
Standard Deviation 26.28
|
73.3 Units on a scale
Standard Deviation 26.46
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 48
|
75.3 Units on a scale
Standard Deviation 14.63
|
72.9 Units on a scale
Standard Deviation 18.99
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Adequacy Score: Week 52
|
74.7 Units on a scale
Standard Deviation 13.56
|
67.8 Units on a scale
Standard Deviation 23.35
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Baseline
|
40.3 Units on a scale
Standard Deviation 17.05
|
41.8 Units on a scale
Standard Deviation 18.51
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 8
|
36.3 Units on a scale
Standard Deviation 10.55
|
39.1 Units on a scale
Standard Deviation 18.89
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 12
|
38.0 Units on a scale
Standard Deviation 14.03
|
41.3 Units on a scale
Standard Deviation 18.81
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 16
|
34.4 Units on a scale
Standard Deviation 10.00
|
40.5 Units on a scale
Standard Deviation 17.38
|
—
|
|
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Sleep Somnolence Score: Week 20
|
42.5 Units on a scale
Standard Deviation 24.67
|
36.9 Units on a scale
Standard Deviation 20.66
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.
Outcome measures
| Measure |
Vehicle QD
n=169 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period
Baseline
|
0.9 Units on a scale
Standard Deviation 0.12
|
—
|
—
|
|
European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period
Week 2
|
0.9 Units on a scale
Standard Deviation 0.13
|
—
|
—
|
|
European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period
Week 4
|
0.9 Units on a scale
Standard Deviation 0.11
|
—
|
—
|
|
European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period
Week 6
|
0.9 Units on a scale
Standard Deviation 0.12
|
—
|
—
|
|
European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period
Week 8
|
0.9 Units on a scale
Standard Deviation 0.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
Outcome measures
| Measure |
Vehicle QD
n=169 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period
Baseline
|
0.9 Units on a scale
Standard Deviation 0.13
|
—
|
—
|
|
European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period
Week 2
|
0.9 Units on a scale
Standard Deviation 0.11
|
—
|
—
|
|
European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period
Week 4
|
0.9 Units on a scale
Standard Deviation 0.12
|
—
|
—
|
|
European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period
Week 6
|
0.9 Units on a scale
Standard Deviation 0.11
|
—
|
—
|
|
European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period
Week 8
|
0.9 Units on a scale
Standard Deviation 0.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant
Outcome measures
| Measure |
Vehicle QD
n=136 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Baseline
|
0.8 Units on a scale
Standard Deviation 0.17 • Interval 0.17 to
|
—
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Week 2
|
0.9 Units on a scale
Standard Deviation 0.16 • Interval 0.16 to
|
—
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Week 4
|
0.9 Units on a scale
Standard Deviation 0.17 • Interval 0.17 to
|
—
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Week 6
|
0.9 Units on a scale
Standard Deviation 0.17 • Interval 0.17 to
|
—
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Week 8
|
0.9 Units on a scale
Standard Deviation 0.18 • Interval 0.18 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-5L VAS was used to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.
Outcome measures
| Measure |
Vehicle QD
n=169 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period
Baseline
|
81.2 Units on a scale
Standard Deviation 15.81
|
—
|
—
|
|
EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period
Week 2
|
82.2 Units on a scale
Standard Deviation 16.14
|
—
|
—
|
|
EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period
Week 4
|
82.0 Units on a scale
Standard Deviation 15.73
|
—
|
—
|
|
EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period
Week 6
|
84.0 Units on a scale
Standard Deviation 14.89
|
—
|
—
|
|
EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period
Week 8
|
84.2 Units on a scale
Standard Deviation 14.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D Y VAS was used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
Outcome measures
| Measure |
Vehicle QD
n=169 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period
Baseline
|
85.6 Units on a scale
Standard Deviation 16.27
|
—
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period
Week 2
|
87.4 Units on a scale
Standard Deviation 11.91
|
—
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period
Week 4
|
87.5 Units on a scale
Standard Deviation 12.92
|
—
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period
Week 6
|
87.9 Units on a scale
Standard Deviation 12.72
|
—
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period
Week 8
|
88.0 Units on a scale
Standard Deviation 12.93
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
Outcome measures
| Measure |
Vehicle QD
n=136 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Baseline
|
86.0 Units on a scale
Standard Deviation 13.97 • Interval 13.97 to
|
—
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Week 2
|
87.6 Units on a scale
Standard Deviation 12.61 • Interval 12.61 to
|
—
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Week 4
|
90.0 Units on a scale
Standard Deviation 11.05 • Interval 11.05 to
|
—
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Week 6
|
90.4 Units on a scale
Standard Deviation 11.45 • Interval 11.45 to
|
—
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Week 8
|
90.8 Units on a scale
Standard Deviation 11.63 • Interval 11.63 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQoL. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.
Outcome measures
| Measure |
Vehicle QD
n=46 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=48 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=35 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 20
|
0.9 Units on a scale
Standard Deviation 0.12
|
0.9 Units on a scale
Standard Deviation 0.15
|
0.9 Units on a scale
Standard Deviation 0.09
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 24
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.21
|
0.9 Units on a scale
Standard Deviation 0.07
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 28
|
0.9 Units on a scale
Standard Deviation 0.18
|
0.9 Units on a scale
Standard Deviation 0.14
|
1.0 Units on a scale
Standard Deviation 0.06
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 32
|
0.9 Units on a scale
Standard Deviation 0.11
|
0.8 Units on a scale
Standard Deviation 0.22
|
0.9 Units on a scale
Standard Deviation 0.10
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 36
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.13
|
1.0 Units on a scale
Standard Deviation 0.09
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 40
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.8 Units on a scale
Standard Deviation 0.24
|
1.0 Units on a scale
Standard Deviation 0.06
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 48
|
0.9 Units on a scale
Standard Deviation 0.11
|
0.8 Units on a scale
Standard Deviation 0.23
|
1.0 Units on a scale
Standard Deviation 0.06
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Baseline
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.11
|
—
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 4
|
0.9 Units on a scale
Standard Deviation 0.12
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.14
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 8
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.17
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 12
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.18
|
0.9 Units on a scale
Standard Deviation 0.09
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 16
|
0.9 Units on a scale
Standard Deviation 0.11
|
0.9 Units on a scale
Standard Deviation 0.15
|
0.9 Units on a scale
Standard Deviation 0.08
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 44
|
0.9 Units on a scale
Standard Deviation 0.18
|
0.9 Units on a scale
Standard Deviation 0.14
|
1.0 Units on a scale
Standard Deviation 0.07
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Week 52
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.8 Units on a scale
Standard Deviation 0.24
|
0.9 Units on a scale
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
Outcome measures
| Measure |
Vehicle QD
n=38 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=43 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=29 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 20
|
0.9 Units on a scale
Standard Deviation 0.09
|
1.0 Units on a scale
Standard Deviation 0.05
|
0.9 Units on a scale
Standard Deviation 0.09
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 28
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.14
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 36
|
1.0 Units on a scale
Standard Deviation 0.08
|
1.0 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.09
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 48
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.09
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Baseline
|
0.9 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.18
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 4
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.21
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 8
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.10
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 12
|
1.0 Units on a scale
Standard Deviation 0.06
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.10
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 16
|
1.0 Units on a scale
Standard Deviation 0.08
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.09
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 24
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.06
|
0.9 Units on a scale
Standard Deviation 0.12
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 32
|
1.0 Units on a scale
Standard Deviation 0.06
|
1.0 Units on a scale
Standard Deviation 0.06
|
0.9 Units on a scale
Standard Deviation 0.11
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 40
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.13
|
1.0 Units on a scale
Standard Deviation 0.08
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 44
|
1.0 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.22
|
0.9 Units on a scale
Standard Deviation 0.09
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Week 52
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant.
Outcome measures
| Measure |
Vehicle QD
n=41 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=30 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=34 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Baseline
|
1.0 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.12
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 20
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.15
|
0.8 Units on a scale
Standard Deviation 0.12
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 28
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.09
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 4
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.14
|
0.8 Units on a scale
Standard Deviation 0.19
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 8
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.8 Units on a scale
Standard Deviation 0.15
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 12
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.13
|
0.8 Units on a scale
Standard Deviation 0.18
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 16
|
1.0 Units on a scale
Standard Deviation 0.09
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.11
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 24
|
1.0 Units on a scale
Standard Deviation 0.08
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.20
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 32
|
1.0 Units on a scale
Standard Deviation 0.06
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.11
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 36
|
1.0 Units on a scale
Standard Deviation 0.05
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.11
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 40
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.12
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 44
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.14
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 48
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.9 Units on a scale
Standard Deviation 0.11
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Week 52
|
1.0 Units on a scale
Standard Deviation 0.05
|
1.0 Units on a scale
Standard Deviation 0.00
|
0.9 Units on a scale
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-5L VAS to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.
Outcome measures
| Measure |
Vehicle QD
n=46 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=48 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=35 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Baseline
|
88.3 Units on a scale
Standard Deviation 9.41
|
85.2 Units on a scale
Standard Deviation 15.56
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 8
|
90.7 Units on a scale
Standard Deviation 7.76
|
87.3 Units on a scale
Standard Deviation 12.02
|
83.8 Units on a scale
Standard Deviation 17.75
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 48
|
88.8 Units on a scale
Standard Deviation 12.90
|
85.1 Units on a scale
Standard Deviation 20.92
|
86.9 Units on a scale
Standard Deviation 11.13
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 52
|
90.0 Units on a scale
Standard Deviation 11.44
|
82.7 Units on a scale
Standard Deviation 20.98
|
83.7 Units on a scale
Standard Deviation 10.55
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 4
|
89.9 Units on a scale
Standard Deviation 9.00
|
86.8 Units on a scale
Standard Deviation 10.74
|
81.9 Units on a scale
Standard Deviation 16.81
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 12
|
88.5 Units on a scale
Standard Deviation 13.72
|
80.5 Units on a scale
Standard Deviation 21.68
|
88.1 Units on a scale
Standard Deviation 8.69
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 16
|
88.1 Units on a scale
Standard Deviation 11.86
|
82.7 Units on a scale
Standard Deviation 18.94
|
88.7 Units on a scale
Standard Deviation 9.00
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 20
|
87.1 Units on a scale
Standard Deviation 13.77
|
82.7 Units on a scale
Standard Deviation 14.47
|
85.3 Units on a scale
Standard Deviation 6.56
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 24
|
89.2 Units on a scale
Standard Deviation 10.98
|
83.1 Units on a scale
Standard Deviation 19.39
|
88.0 Units on a scale
Standard Deviation 8.93
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 28
|
88.3 Units on a scale
Standard Deviation 9.29
|
83.7 Units on a scale
Standard Deviation 16.57
|
81.2 Units on a scale
Standard Deviation 7.26
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 32
|
90.0 Units on a scale
Standard Deviation 8.91
|
83.0 Units on a scale
Standard Deviation 20.02
|
83.2 Units on a scale
Standard Deviation 13.37
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 36
|
90.8 Units on a scale
Standard Deviation 8.68
|
83.4 Units on a scale
Standard Deviation 12.80
|
86.8 Units on a scale
Standard Deviation 8.30
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 40
|
88.9 Units on a scale
Standard Deviation 12.99
|
82.4 Units on a scale
Standard Deviation 20.68
|
93.8 Units on a scale
Standard Deviation 5.76
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Week 44
|
87.2 Units on a scale
Standard Deviation 13.64
|
81.9 Units on a scale
Standard Deviation 13.96
|
87.0 Units on a scale
Standard Deviation 10.26
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
Outcome measures
| Measure |
Vehicle QD
n=38 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=43 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=29 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 8
|
89.6 Units on a scale
Standard Deviation 9.52
|
88.6 Units on a scale
Standard Deviation 14.34
|
89.6 Units on a scale
Standard Deviation 8.36
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 44
|
93.5 Units on a scale
Standard Deviation 8.70
|
88.3 Units on a scale
Standard Deviation 15.81
|
88.0 Units on a scale
Standard Deviation 11.16
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Baseline
|
86.8 Units on a scale
Standard Deviation 14.86
|
91.1 Units on a scale
Standard Deviation 9.34
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 4
|
88.3 Units on a scale
Standard Deviation 11.29
|
91.6 Units on a scale
Standard Deviation 7.27
|
84.7 Units on a scale
Standard Deviation 14.13
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 12
|
91.9 Units on a scale
Standard Deviation 9.18
|
89.1 Units on a scale
Standard Deviation 13.36
|
87.9 Units on a scale
Standard Deviation 13.50
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 16
|
91.3 Units on a scale
Standard Deviation 8.20
|
88.9 Units on a scale
Standard Deviation 13.91
|
87.6 Units on a scale
Standard Deviation 9.87
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 20
|
85.1 Units on a scale
Standard Deviation 10.89
|
87.8 Units on a scale
Standard Deviation 21.65
|
90.1 Units on a scale
Standard Deviation 9.43
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 24
|
91.7 Units on a scale
Standard Deviation 10.92
|
89.3 Units on a scale
Standard Deviation 12.83
|
88.0 Units on a scale
Standard Deviation 11.94
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 28
|
89.9 Units on a scale
Standard Deviation 12.09
|
90.4 Units on a scale
Standard Deviation 13.36
|
84.8 Units on a scale
Standard Deviation 12.56
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 32
|
91.1 Units on a scale
Standard Deviation 9.40
|
91.5 Units on a scale
Standard Deviation 12.98
|
88.7 Units on a scale
Standard Deviation 9.89
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 36
|
90.7 Units on a scale
Standard Deviation 10.34
|
91.7 Units on a scale
Standard Deviation 14.86
|
88.5 Units on a scale
Standard Deviation 10.88
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 40
|
92.2 Units on a scale
Standard Deviation 9.03
|
89.8 Units on a scale
Standard Deviation 13.25
|
90.6 Units on a scale
Standard Deviation 10.02
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 48
|
92.1 Units on a scale
Standard Deviation 9.75
|
91.3 Units on a scale
Standard Deviation 13.64
|
96.1 Units on a scale
Standard Deviation 5.18
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Week 52
|
90.9 Units on a scale
Standard Deviation 13.75
|
92.6 Units on a scale
Standard Deviation 11.27
|
93.6 Units on a scale
Standard Deviation 7.91
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
Outcome measures
| Measure |
Vehicle QD
n=41 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=30 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=34 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 8
|
93.0 Units on a scale
Standard Deviation 7.39
|
96.3 Units on a scale
Standard Deviation 6.17
|
91.8 Units on a scale
Standard Deviation 7.49
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 16
|
92.9 Units on a scale
Standard Deviation 7.08
|
96.5 Units on a scale
Standard Deviation 2.81
|
93.2 Units on a scale
Standard Deviation 6.29
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 24
|
95.1 Units on a scale
Standard Deviation 5.62
|
95.7 Units on a scale
Standard Deviation 4.62
|
91.9 Units on a scale
Standard Deviation 7.77
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 28
|
95.8 Units on a scale
Standard Deviation 5.60
|
97.1 Units on a scale
Standard Deviation 4.17
|
93.2 Units on a scale
Standard Deviation 5.65
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 32
|
95.5 Units on a scale
Standard Deviation 5.70
|
96.9 Units on a scale
Standard Deviation 2.12
|
93.1 Units on a scale
Standard Deviation 6.98
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 36
|
97.4 Units on a scale
Standard Deviation 2.99
|
97.8 Units on a scale
Standard Deviation 2.49
|
93.5 Units on a scale
Standard Deviation 5.71
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 40
|
93.7 Units on a scale
Standard Deviation 7.76
|
96.8 Units on a scale
Standard Deviation 3.46
|
92.9 Units on a scale
Standard Deviation 5.28
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Baseline
|
93.8 Units on a scale
Standard Deviation 9.97
|
94.3 Units on a scale
Standard Deviation 8.16
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 4
|
94.6 Units on a scale
Standard Deviation 5.86
|
96.3 Units on a scale
Standard Deviation 6.54
|
89.4 Units on a scale
Standard Deviation 11.28
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 12
|
95.2 Units on a scale
Standard Deviation 5.47
|
96.8 Units on a scale
Standard Deviation 3.73
|
91.5 Units on a scale
Standard Deviation 10.81
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 20
|
94.9 Units on a scale
Standard Deviation 5.09
|
93.4 Units on a scale
Standard Deviation 6.50
|
92.7 Units on a scale
Standard Deviation 5.07
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 44
|
96.6 Units on a scale
Standard Deviation 4.60
|
97.8 Units on a scale
Standard Deviation 2.71
|
93.0 Units on a scale
Standard Deviation 5.14
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 48
|
96.1 Units on a scale
Standard Deviation 5.15
|
96.9 Units on a scale
Standard Deviation 4.01
|
93.4 Units on a scale
Standard Deviation 5.57
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Week 52
|
95.0 Units on a scale
Standard Deviation 5.51
|
96.7 Units on a scale
Standard Deviation 3.97
|
96.6 Units on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.
Outcome measures
| Measure |
Vehicle QD
n=27 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=28 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period
Week 4
|
1.0 Units on a scale
Standard Deviation 0.07
|
0.8 Units on a scale
Standard Deviation 0.19
|
—
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period
Week 12
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.10
|
—
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period
Week 0
|
0.9 Units on a scale
Standard Deviation 0.11
|
0.9 Units on a scale
Standard Deviation 0.15
|
—
|
|
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period
Week 8
|
1.0 Units on a scale
Standard Deviation 0.06
|
0.8 Units on a scale
Standard Deviation 0.07
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
Outcome measures
| Measure |
Vehicle QD
n=28 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=22 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period
Week 0
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.8 Units on a scale
Standard Deviation 0.25
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period
Week 8
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.11
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period
Week 4
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.13
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period
Week 12
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
0.9 Units on a scale
Standard Deviation 0.09
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant.
Outcome measures
| Measure |
Vehicle QD
n=30 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=23 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period
Week 0
|
0.8 Units on a scale
Standard Deviation 0.22
|
0.8 Units on a scale
Standard Deviation 0.15
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period
Week 4
|
0.9 Units on a scale
Standard Deviation 0.18
|
0.9 Units on a scale
Standard Deviation 0.16
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period
Week 8
|
0.9 Units on a scale
Standard Deviation 0.11
|
0.8 Units on a scale
Standard Deviation 0.20
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period
Week 12
|
0.9 Units on a scale
Standard Deviation 0.10
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-5L VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Outcome measures
| Measure |
Vehicle QD
n=27 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=28 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period
Week 8
|
88.6 Units on a scale
Standard Deviation 6.71
|
88.2 Units on a scale
Standard Deviation 9.25
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period
Week 0
|
84.1 Units on a scale
Standard Deviation 10.40
|
82.8 Units on a scale
Standard Deviation 17.81
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period
Week 4
|
87.9 Units on a scale
Standard Deviation 8.02
|
81.1 Units on a scale
Standard Deviation 22.15
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period
Week 12
|
83.7 Units on a scale
Standard Deviation 11.85
|
85.0 Units on a scale
Standard Deviation 21.79
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
Outcome measures
| Measure |
Vehicle QD
n=28 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=22 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period
Baseline
|
86.5 Units on a scale
Standard Deviation 10.87
|
88.7 Units on a scale
Standard Deviation 10.27
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period
Week 4
|
91.5 Units on a scale
Standard Deviation 8.91
|
82.3 Units on a scale
Standard Deviation 18.55
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period
Week 8
|
85.3 Units on a scale
Standard Deviation 17.58
|
87.0 Units on a scale
Standard Deviation 9.49
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period
Week 12
|
100.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
81.0 Units on a scale
Standard Deviation 4.18
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
Outcome measures
| Measure |
Vehicle QD
n=30 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=23 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period
Week 12
|
90.0 Units on a scale
Standard Deviation 10.61
|
99.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period
Week 0
|
84.7 Units on a scale
Standard Deviation 21.55
|
91.0 Units on a scale
Standard Deviation 7.84
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period
Week 4
|
90.3 Units on a scale
Standard Deviation 13.53
|
91.3 Units on a scale
Standard Deviation 7.69
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period
Week 8
|
93.8 Units on a scale
Standard Deviation 5.29
|
93.0 Units on a scale
Standard Deviation 7.90
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
Outcome measures
| Measure |
Vehicle QD
n=46 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=48 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 12
|
1.0 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.09
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Baseline
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.11
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 4
|
0.9 Units on a scale
Standard Deviation 0.12
|
0.9 Units on a scale
Standard Deviation 0.10
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 8
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.09
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 16
|
0.9 Units on a scale
Standard Deviation 0.11
|
0.9 Units on a scale
Standard Deviation 0.10
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 20
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.15
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 24
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.10
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 28
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 32
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.12
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 36
|
0.9 Units on a scale
Standard Deviation 0.08
|
1.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 40
|
1.0 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.18
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 44
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.07
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 48
|
0.9 Units on a scale
Standard Deviation 0.11
|
0.9 Units on a scale
Standard Deviation 0.11
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 52
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.12
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
Outcome measures
| Measure |
Vehicle QD
n=38 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=43 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 36
|
—
|
1.0 Units on a scale
Standard Deviation 0.08
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 48
|
1.0 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.09
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 52
|
1.0 Units on a scale
Standard Deviation 0.09
|
1.0 Units on a scale
Standard Deviation 0.07
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Baseline
|
0.9 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.18
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 4
|
1.0 Units on a scale
Standard Deviation 0.06
|
1.0 Units on a scale
Standard Deviation 0.07
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 8
|
1.0 Units on a scale
Standard Deviation 0.05
|
1.0 Units on a scale
Standard Deviation 0.08
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 12
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.06
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 16
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.07
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 20
|
0.8 Units on a scale
Standard Deviation 0.01
|
1.0 Units on a scale
Standard Deviation 0.05
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 24
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.06
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 28
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
1.0 Units on a scale
Standard Deviation 0.07
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 32
|
1.0 Units on a scale
Standard Deviation 0.07
|
1.0 Units on a scale
Standard Deviation 0.07
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 40
|
0.9 Units on a scale
Standard Deviation 0.09
|
0.9 Units on a scale
Standard Deviation 0.14
|
—
|
|
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 44
|
—
|
0.9 Units on a scale
Standard Deviation 0.25
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant.
Outcome measures
| Measure |
Vehicle QD
n=41 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=30 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Baseline
|
1.0 Units on a scale
Standard Deviation 0.08
|
0.9 Units on a scale
Standard Deviation 0.12
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 4
|
0.9 Units on a scale
Standard Deviation 0.10
|
0.9 Units on a scale
Standard Deviation 0.14
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 8
|
1.0 Units on a scale
Standard Deviation 0.08
|
1.0 Units on a scale
Standard Deviation 0.08
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 12
|
1.0 Units on a scale
Standard Deviation 0.09
|
1.0 Units on a scale
Standard Deviation 0.06
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 16
|
0.9 Units on a scale
Standard Deviation 0.09
|
1.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 20
|
0.9 Units on a scale
Standard Deviation 0.12
|
1.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 24
|
0.9 Units on a scale
Standard Deviation 0.08
|
1.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 28
|
0.9 Units on a scale
Standard Deviation 0.12
|
0.9 Units on a scale
Standard Deviation 0.09
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 32
|
0.9 Units on a scale
Standard Deviation 0.11
|
1.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 36
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
1.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 40
|
0.9 Units on a scale
Standard Deviation 0.11
|
1.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 44
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
1.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 48
|
0.9 Units on a scale
Standard Deviation 0.11
|
1.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 52
|
1.0 Units on a scale
Standard Deviation 0.06
|
1.0 Units on a scale
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D-5L VAS was used to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.
Outcome measures
| Measure |
Vehicle QD
n=46 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=48 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 4
|
89.6 Units on a scale
Standard Deviation 9.11
|
86.8 Units on a scale
Standard Deviation 10.74
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 8
|
91.3 Units on a scale
Standard Deviation 7.44
|
88.5 Units on a scale
Standard Deviation 11.29
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Baseline
|
88.3 Units on a scale
Standard Deviation 9.41
|
85.2 Units on a scale
Standard Deviation 15.56
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 12
|
91.9 Units on a scale
Standard Deviation 8.86
|
83.8 Units on a scale
Standard Deviation 15.36
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 16
|
91.3 Units on a scale
Standard Deviation 9.74
|
86.1 Units on a scale
Standard Deviation 11.88
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 20
|
88.1 Units on a scale
Standard Deviation 12.01
|
87.5 Units on a scale
Standard Deviation 14.01
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 24
|
92.6 Units on a scale
Standard Deviation 8.26
|
88.1 Units on a scale
Standard Deviation 9.77
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 28
|
91.9 Units on a scale
Standard Deviation 7.06
|
96.3 Units on a scale
Standard Deviation 2.75
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 32
|
91.5 Units on a scale
Standard Deviation 6.70
|
89.5 Units on a scale
Standard Deviation 8.88
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 36
|
91.3 Units on a scale
Standard Deviation 9.83
|
92.7 Units on a scale
Standard Deviation 10.12
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 40
|
93.1 Units on a scale
Standard Deviation 7.95
|
87.2 Units on a scale
Standard Deviation 13.76
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 44
|
91.1 Units on a scale
Standard Deviation 9.63
|
88.0 Units on a scale
Standard Deviation 11.78
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 48
|
92.5 Units on a scale
Standard Deviation 9.28
|
92.4 Units on a scale
Standard Deviation 8.17
|
—
|
|
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Week 52
|
93.7 Units on a scale
Standard Deviation 7.75
|
88.9 Units on a scale
Standard Deviation 9.70
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
Outcome measures
| Measure |
Vehicle QD
n=38 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=43 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Baseline
|
86.8 Units on a scale
Standard Deviation 14.86
|
91.1 Units on a scale
Standard Deviation 9.34
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 4
|
87.7 Units on a scale
Standard Deviation 11.74
|
91.6 Units on a scale
Standard Deviation 7.27
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 8
|
88.8 Units on a scale
Standard Deviation 10.96
|
87.6 Units on a scale
Standard Deviation 14.84
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 12
|
89.8 Units on a scale
Standard Deviation 11.01
|
87.9 Units on a scale
Standard Deviation 13.70
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 16
|
92.9 Units on a scale
Standard Deviation 8.01
|
87.9 Units on a scale
Standard Deviation 14.74
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 20
|
84.0 Units on a scale
Standard Deviation 12.73
|
86.1 Units on a scale
Standard Deviation 23.22
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 24
|
92.7 Units on a scale
Standard Deviation 12.04
|
89.8 Units on a scale
Standard Deviation 13.76
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 28
|
96.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
86.6 Units on a scale
Standard Deviation 15.40
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 32
|
92.1 Units on a scale
Standard Deviation 8.43
|
88.8 Units on a scale
Standard Deviation 14.68
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 36
|
—
|
89.0 Units on a scale
Standard Deviation 18.25
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 40
|
95.2 Units on a scale
Standard Deviation 4.75
|
89.6 Units on a scale
Standard Deviation 14.01
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 44
|
—
|
88.0 Units on a scale
Standard Deviation 16.46
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 48
|
93.8 Units on a scale
Standard Deviation 7.50
|
89.1 Units on a scale
Standard Deviation 15.72
|
—
|
|
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Week 52
|
98.5 Units on a scale
Standard Deviation 1.91
|
90.7 Units on a scale
Standard Deviation 13.53
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
Outcome measures
| Measure |
Vehicle QD
n=41 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=30 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Baseline
|
93.8 Units on a scale
Standard Deviation 9.97
|
94.3 Units on a scale
Standard Deviation 8.16
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 4
|
94.6 Units on a scale
Standard Deviation 6.05
|
96.3 Units on a scale
Standard Deviation 6.54
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 8
|
94.3 Units on a scale
Standard Deviation 7.06
|
96.0 Units on a scale
Standard Deviation 7.29
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 12
|
94.4 Units on a scale
Standard Deviation 5.95
|
98.3 Units on a scale
Standard Deviation 2.26
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 16
|
93.7 Units on a scale
Standard Deviation 8.22
|
98.2 Units on a scale
Standard Deviation 2.23
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 20
|
96.5 Units on a scale
Standard Deviation 4.95
|
93.7 Units on a scale
Standard Deviation 10.97
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 24
|
90.0 Units on a scale
Standard Deviation 8.49
|
95.7 Units on a scale
Standard Deviation 5.01
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 28
|
100.0 Units on a scale
Standard Deviation 0.00
|
100.0 Units on a scale
Standard Deviation 0.00
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 32
|
92.0 Units on a scale
Standard Deviation 8.45
|
97.8 Units on a scale
Standard Deviation 1.71
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 36
|
100.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
98.3 Units on a scale
Standard Deviation 2.89
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 40
|
91.5 Units on a scale
Standard Deviation 9.33
|
99.3 Units on a scale
Standard Deviation 0.58
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 44
|
100.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
100.0 Units on a scale
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 48
|
94.0 Units on a scale
Standard Deviation 5.35
|
99.0 Units on a scale
Standard Deviation 1.73
|
—
|
|
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Week 52
|
96.4 Units on a scale
Standard Deviation 4.16
|
98.7 Units on a scale
Standard Deviation 2.31
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI plus CIQ was a 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1= currently employed; Q2= work hours missed due to health problems; Q3= work hours missed due to other reasons; Q4= hours actually worked; Q5= degree health affected productivity while working (0-10 scale, higher scores = less productivity); Q6= classes attended in academic setting or not; Q7= class hours missed due to health problems; Q8= class hours actually attended; Q9= degree health affected productivity while attending (0-10 scale, high scores= less productivity); Q10= degree health affected productivity in regular daily activities (0-10 scale, higher scores = less productivity). Percent work time missed was calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%, higher scores = greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=135 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Baseline
|
5.75 Percentage of work time missed
Standard Deviation 16.796
|
—
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 2
|
4.72 Percentage of work time missed
Standard Deviation 15.553
|
—
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 4
|
5.92 Percentage of work time missed
Standard Deviation 16.487
|
—
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 6
|
4.83 Percentage of work time missed
Standard Deviation 14.801
|
—
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 8
|
6.96 Percentage of work time missed
Standard Deviation 18.080
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were:Q1= currently employed;Q2= work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4= hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7= class hours missed due to health problems; Q8= class hours actually attended; Q9= degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10= degree health affected productivity in regular daily activities (0-10 scale, high scores=less productivity). Percent impairment while working due to health problem was calculated as: 100\*Q5/10 and score ranged from 0-100%,higher scores =greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=135 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 0
|
32.66 Percentage of work impairment
Standard Deviation 28.602
|
—
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 2
|
17.02 Percentage of work impairment
Standard Deviation 21.293
|
—
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 4
|
15.26 Percentage of work impairment
Standard Deviation 20.285
|
—
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 6
|
14.10 Percentage of work impairment
Standard Deviation 20.417
|
—
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 8
|
14.37 Percentage of work impairment
Standard Deviation 20.898
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity: regular daily activities (0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]},score ranged:0-100%,high numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=135 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 0
|
34.77 Percentage of work impairment
Standard Deviation 30.179
|
—
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 2
|
20.10 Percentage of work impairment
Standard Deviation 23.627
|
—
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 4
|
19.30 Percentage of work impairment
Standard Deviation 23.220
|
—
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 6
|
17.43 Percentage of work impairment
Standard Deviation 22.620
|
—
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Week 8
|
19.36 Percentage of work impairment
Standard Deviation 24.564
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity).Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=118 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Baseline
|
4.14 Percent class time missed
Standard Deviation 14.982
|
—
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 2
|
5.26 Percent class time missed
Standard Deviation 16.664
|
—
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 4
|
3.94 Percent class time missed
Standard Deviation 12.968
|
—
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 6
|
4.71 Percent class time missed
Standard Deviation 13.991
|
—
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 8
|
4.55 Percent class time missed
Standard Deviation 14.584
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=119 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Baseline
|
26.46 Percent impairment in class
Standard Deviation 22.683
|
—
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 2
|
17.55 Percent impairment in class
Standard Deviation 19.639
|
—
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 4
|
15.37 Percent impairment in class
Standard Deviation 19.879
|
—
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 6
|
13.31 Percent impairment in class
Standard Deviation 19.527
|
—
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 8
|
12.69 Percent impairment in class
Standard Deviation 17.789
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity).Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]},score range:0-100%,higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=118 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 4
|
18.13 Percent overall class impairment
Standard Deviation 22.977
|
—
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 6
|
17.01 Percent overall class impairment
Standard Deviation 23.126
|
—
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 8
|
16.20 Percent overall class impairment
Standard Deviation 22.148
|
—
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Baseline
|
28.20 Percent overall class impairment
Standard Deviation 24.171
|
—
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 2
|
20.27 Percent overall class impairment
Standard Deviation 22.676
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=273 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Baseline
|
28.21 Percent activity impairment
Standard Deviation 28.766
|
—
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 2
|
15.83 Percent activity impairment
Standard Deviation 20.036
|
—
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 4
|
14.54 Percent activity impairment
Standard Deviation 20.162
|
—
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 6
|
13.81 Percent activity impairment
Standard Deviation 20.547
|
—
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Week 8
|
13.55 Percent activity impairment
Standard Deviation 19.783
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores=less productivity). Percent work time missed due to health problem calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=69 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=78 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=88 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 4
|
5.67 Percent work time missed
Standard Deviation 14.861
|
5.54 Percent work time missed
Standard Deviation 15.120
|
2.80 Percent work time missed
Standard Deviation 10.617
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 12
|
3.98 Percent work time missed
Standard Deviation 13.835
|
3.85 Percent work time missed
Standard Deviation 12.970
|
6.81 Percent work time missed
Standard Deviation 16.477
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 16
|
14.84 Percent work time missed
Standard Deviation 30.656
|
3.55 Percent work time missed
Standard Deviation 10.903
|
6.25 Percent work time missed
Standard Deviation 17.678
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 20
|
4.34 Percent work time missed
Standard Deviation 9.633
|
0.37 Percent work time missed
Standard Deviation 0.898
|
10.00 Percent work time missed
Standard Deviation 22.361
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 24
|
0.37 Percent work time missed
Standard Deviation 0.997
|
7.24 Percent work time missed
Standard Deviation 17.750
|
18.76 Percent work time missed
Standard Deviation 29.995
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 32
|
5.55 Percent work time missed
Standard Deviation 14.500
|
9.22 Percent work time missed
Standard Deviation 25.636
|
18.27 Percent work time missed
Standard Deviation 31.639
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 40
|
1.91 Percent work time missed
Standard Deviation 6.181
|
3.02 Percent work time missed
Standard Deviation 11.770
|
0.00 Percent work time missed
Standard Deviation 0.000
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Baseline
|
4.77 Percent work time missed
Standard Deviation 14.528
|
5.07 Percent work time missed
Standard Deviation 14.128
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 8
|
5.48 Percent work time missed
Standard Deviation 14.237
|
2.99 Percent work time missed
Standard Deviation 12.345
|
1.41 Percent work time missed
Standard Deviation 3.066
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 28
|
0.36 Percent work time missed
Standard Deviation 0.805
|
0.82 Percent work time missed
Standard Deviation 1.834
|
4.73 Percent work time missed
Standard Deviation 9.450
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 36
|
5.00 Percent work time missed
Standard Deviation 11.180
|
0.84 Percent work time missed
Standard Deviation 1.878
|
3.58 Percent work time missed
Standard Deviation 7.150
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 44
|
0.27 Percent work time missed
Standard Deviation 0.653
|
0.70 Percent work time missed
Standard Deviation 1.715
|
2.08 Percent work time missed
Standard Deviation 4.150
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 48
|
1.44 Percent work time missed
Standard Deviation 3.746
|
11.51 Percent work time missed
Standard Deviation 21.033
|
5.55 Percent work time missed
Standard Deviation 13.595
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 52
|
11.27 Percent work time missed
Standard Deviation 20.344
|
5.00 Percent work time missed
Standard Deviation 12.884
|
0.00 Percent work time missed
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100\*Q5/10 score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=69 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=78 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=88 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Baseline
|
9.71 Percent impairment while work
Standard Deviation 15.432
|
10.26 Percent impairment while work
Standard Deviation 17.474
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 4
|
4.55 Percent impairment while work
Standard Deviation 12.136
|
10.56 Percent impairment while work
Standard Deviation 15.136
|
15.22 Percent impairment while work
Standard Deviation 25.561
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 16
|
11.76 Percent impairment while work
Standard Deviation 15.506
|
5.24 Percent impairment while work
Standard Deviation 14.359
|
11.25 Percent impairment while work
Standard Deviation 21.002
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 40
|
9.33 Percent impairment while work
Standard Deviation 10.998
|
10.56 Percent impairment while work
Standard Deviation 19.844
|
6.67 Percent impairment while work
Standard Deviation 11.547
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 44
|
21.67 Percent impairment while work
Standard Deviation 32.506
|
11.67 Percent impairment while work
Standard Deviation 24.014
|
5.00 Percent impairment while work
Standard Deviation 10.000
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 8
|
6.15 Percent impairment while work
Standard Deviation 7.679
|
5.29 Percent impairment while work
Standard Deviation 12.805
|
9.38 Percent impairment while work
Standard Deviation 16.520
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 12
|
6.92 Percent impairment while work
Standard Deviation 8.549
|
8.00 Percent impairment while work
Standard Deviation 20.771
|
7.78 Percent impairment while work
Standard Deviation 13.017
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 20
|
11.25 Percent impairment while work
Standard Deviation 15.526
|
3.33 Percent impairment while work
Standard Deviation 5.164
|
10.00 Percent impairment while work
Standard Deviation 12.247
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 24
|
8.00 Percent impairment while work
Standard Deviation 8.619
|
8.89 Percent impairment while work
Standard Deviation 20.260
|
10.00 Percent impairment while work
Standard Deviation 17.321
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 28
|
12.00 Percent impairment while work
Standard Deviation 13.038
|
0.00 Percent impairment while work
Standard Deviation 0.000
|
5.00 Percent impairment while work
Standard Deviation 5.774
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 32
|
7.69 Percent impairment while work
Standard Deviation 8.321
|
9.41 Percent impairment while work
Standard Deviation 15.996
|
0.00 Percent impairment while work
Standard Deviation 0.000
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 36
|
10.00 Percent impairment while work
Standard Deviation 10.000
|
10.00 Percent impairment while work
Standard Deviation 10.000
|
2.50 Percent impairment while work
Standard Deviation 5.000
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 48
|
9.17 Percent impairment while work
Standard Deviation 9.003
|
13.33 Percent impairment while work
Standard Deviation 21.269
|
15.00 Percent impairment while work
Standard Deviation 22.583
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 52
|
8.00 Percent impairment while work
Standard Deviation 9.411
|
10.63 Percent impairment while work
Standard Deviation 20.484
|
10.00 Percent impairment while work
Standard Deviation 10.000
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity: regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]}, score ranged: 0-100%, high numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=69 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=78 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=88 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Baseline
|
14.04 Percent overall work impairment
Standard Deviation 19.991
|
14.29 Percent overall work impairment
Standard Deviation 21.183
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 4
|
10.20 Percent overall work impairment
Standard Deviation 17.730
|
15.53 Percent overall work impairment
Standard Deviation 20.088
|
15.80 Percent overall work impairment
Standard Deviation 25.411
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 8
|
11.46 Percent overall work impairment
Standard Deviation 14.980
|
8.29 Percent overall work impairment
Standard Deviation 16.813
|
10.73 Percent overall work impairment
Standard Deviation 16.268
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 12
|
10.11 Percent overall work impairment
Standard Deviation 16.906
|
9.13 Percent overall work impairment
Standard Deviation 23.216
|
14.04 Percent overall work impairment
Standard Deviation 19.828
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 16
|
21.06 Percent overall work impairment
Standard Deviation 24.410
|
7.17 Percent overall work impairment
Standard Deviation 19.121
|
17.50 Percent overall work impairment
Standard Deviation 24.349
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 20
|
15.15 Percent overall work impairment
Standard Deviation 17.456
|
3.67 Percent overall work impairment
Standard Deviation 5.715
|
19.00 Percent overall work impairment
Standard Deviation 23.558
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 36
|
14.50 Percent overall work impairment
Standard Deviation 14.186
|
10.76 Percent overall work impairment
Standard Deviation 10.143
|
5.73 Percent overall work impairment
Standard Deviation 11.450
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 44
|
21.93 Percent overall work impairment
Standard Deviation 32.299
|
12.37 Percent overall work impairment
Standard Deviation 23.664
|
7.08 Percent overall work impairment
Standard Deviation 9.463
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 48
|
10.36 Percent overall work impairment
Standard Deviation 10.518
|
20.64 Percent overall work impairment
Standard Deviation 28.599
|
20.55 Percent overall work impairment
Standard Deviation 22.249
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 52
|
17.91 Percent overall work impairment
Standard Deviation 21.428
|
14.68 Percent overall work impairment
Standard Deviation 23.128
|
10.00 Percent overall work impairment
Standard Deviation 10.000
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 24
|
8.33 Percent overall work impairment
Standard Deviation 8.906
|
15.35 Percent overall work impairment
Standard Deviation 25.202
|
22.76 Percent overall work impairment
Standard Deviation 35.623
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 28
|
12.32 Percent overall work impairment
Standard Deviation 12.997
|
0.82 Percent overall work impairment
Standard Deviation 1.834
|
9.25 Percent overall work impairment
Standard Deviation 12.738
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 32
|
12.69 Percent overall work impairment
Standard Deviation 16.267
|
11.35 Percent overall work impairment
Standard Deviation 20.568
|
18.27 Percent overall work impairment
Standard Deviation 31.639
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 40
|
11.01 Percent overall work impairment
Standard Deviation 12.629
|
11.33 Percent overall work impairment
Standard Deviation 21.941
|
6.67 Percent overall work impairment
Standard Deviation 11.547
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=69 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=78 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=88 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Baseline
|
0.04 Percent class time missed
Standard Deviation 0.223
|
2.22 Percent class time missed
Standard Deviation 9.030
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 4
|
0.89 Percent class time missed
Standard Deviation 3.089
|
1.14 Percent class time missed
Standard Deviation 5.330
|
5.96 Percent class time missed
Standard Deviation 14.570
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 8
|
0.00 Percent class time missed
Standard Deviation 0.000
|
1.62 Percent class time missed
Standard Deviation 6.735
|
7.95 Percent class time missed
Standard Deviation 18.375
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 16
|
0.00 Percent class time missed
Standard Deviation 0.000
|
7.64 Percent class time missed
Standard Deviation 23.561
|
0.81 Percent class time missed
Standard Deviation 2.154
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 20
|
7.79 Percent class time missed
Standard Deviation 20.599
|
0.00 Percent class time missed
Standard Deviation 0.000
|
25.00 Percent class time missed
Standard Deviation 50.000
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 24
|
0.00 Percent class time missed
Standard Deviation 0.000
|
3.62 Percent class time missed
Standard Deviation 9.881
|
0.00 Percent class time missed
Standard Deviation 0.000
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 28
|
0.00 Percent class time missed
Standard Deviation 0.000
|
0.00 Percent class time missed
Standard Deviation 0.000
|
0.00 Percent class time missed
Standard Deviation 0.000
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 32
|
0.00 Percent class time missed
Standard Deviation 0.000
|
5.83 Percent class time missed
Standard Deviation 15.897
|
0.00 Percent class time missed
Standard Deviation 0.000
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 40
|
0.00 Percent class time missed
Standard Deviation 0.000
|
3.57 Percent class time missed
Standard Deviation 13.363
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 44
|
0.00 Percent class time missed
Standard Deviation 0.000
|
0.00 Percent class time missed
Standard Deviation 0.000
|
0.00 Percent class time missed
Standard Deviation 0.000
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 48
|
11.11 Percent class time missed
Standard Deviation 33.333
|
0.00 Percent class time missed
Standard Deviation 0.000
|
10.00 Percent class time missed
Standard Deviation 22.361
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 52
|
5.71 Percent class time missed
Standard Deviation 15.119
|
9.09 Percent class time missed
Standard Deviation 25.054
|
0.00 Percent class time missed
Standard Deviation 0.000
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 12
|
11.36 Percent class time missed
Standard Deviation 32.138
|
3.09 Percent class time missed
Standard Deviation 11.781
|
7.14 Percent class time missed
Standard Deviation 18.898
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 36
|
0.00 Percent class time missed
Standard Deviation 0.000
|
0.00 Percent class time missed
Standard Deviation 0.000
|
0.00 Percent class time missed
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=69 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=78 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=88 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 24
|
8.75 Percent impairment while in class
Standard Deviation 18.077
|
4.00 Percent impairment while in class
Standard Deviation 7.539
|
15.00 Percent impairment while in class
Standard Deviation 23.805
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 28
|
10.00 Percent impairment while in class
Standard Deviation 22.361
|
7.14 Percent impairment while in class
Standard Deviation 11.127
|
21.43 Percent impairment while in class
Standard Deviation 21.157
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 32
|
3.75 Percent impairment while in class
Standard Deviation 10.607
|
3.50 Percent impairment while in class
Standard Deviation 9.333
|
20.00 Percent impairment while in class
Standard Deviation 25.166
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 36
|
2.50 Percent impairment while in class
Standard Deviation 5.000
|
2.50 Percent impairment while in class
Standard Deviation 5.000
|
20.00 Percent impairment while in class
Standard Deviation 28.284
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 40
|
2.00 Percent impairment while in class
Standard Deviation 4.472
|
8.57 Percent impairment while in class
Standard Deviation 14.064
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 44
|
10.00 Percent impairment while in class
Standard Deviation 14.142
|
6.67 Percent impairment while in class
Standard Deviation 8.165
|
16.67 Percent impairment while in class
Standard Deviation 5.774
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 48
|
7.50 Percent impairment while in class
Standard Deviation 13.887
|
7.06 Percent impairment while in class
Standard Deviation 12.127
|
8.00 Percent impairment while in class
Standard Deviation 8.367
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 52
|
1.43 Percent impairment while in class
Standard Deviation 3.780
|
7.62 Percent impairment while in class
Standard Deviation 14.458
|
5.56 Percent impairment while in class
Standard Deviation 8.819
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Baseline
|
8.62 Percent impairment while in class
Standard Deviation 14.072
|
7.88 Percent impairment while in class
Standard Deviation 11.390
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 4
|
5.83 Percent impairment while in class
Standard Deviation 12.401
|
6.36 Percent impairment while in class
Standard Deviation 12.168
|
29.33 Percent impairment while in class
Standard Deviation 26.583
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 8
|
4.17 Percent impairment while in class
Standard Deviation 7.930
|
5.79 Percent impairment while in class
Standard Deviation 8.377
|
19.17 Percent impairment while in class
Standard Deviation 23.916
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 12
|
3.75 Percent impairment while in class
Standard Deviation 7.440
|
2.22 Percent impairment while in class
Standard Deviation 7.321
|
24.29 Percent impairment while in class
Standard Deviation 17.182
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 16
|
7.78 Percent impairment while in class
Standard Deviation 16.415
|
8.57 Percent impairment while in class
Standard Deviation 10.271
|
24.29 Percent impairment while in class
Standard Deviation 29.358
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 20
|
11.43 Percent impairment while in class
Standard Deviation 16.762
|
11.11 Percent impairment while in class
Standard Deviation 26.667
|
10.00 Percent impairment while in class
Standard Deviation 10.000
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]}, score range:0-100%, higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=69 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=78 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=88 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 8
|
4.17 Percent overall class impairment
Standard Deviation 7.930
|
7.40 Percent overall class impairment
Standard Deviation 9.858
|
26.68 Percent overall class impairment
Standard Deviation 25.384
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 20
|
18.44 Percent overall class impairment
Standard Deviation 24.535
|
11.11 Percent overall class impairment
Standard Deviation 26.667
|
10.00 Percent overall class impairment
Standard Deviation 10.000
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 24
|
8.75 Percent overall class impairment
Standard Deviation 18.077
|
7.20 Percent overall class impairment
Standard Deviation 13.260
|
15.00 Percent overall class impairment
Standard Deviation 23.805
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 28
|
10.00 Percent overall class impairment
Standard Deviation 22.361
|
7.14 Percent overall class impairment
Standard Deviation 11.127
|
21.43 Percent overall class impairment
Standard Deviation 21.157
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 32
|
3.75 Percent overall class impairment
Standard Deviation 10.607
|
9.06 Percent overall class impairment
Standard Deviation 18.186
|
20.00 Percent overall class impairment
Standard Deviation 25.166
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 52
|
7.14 Percent overall class impairment
Standard Deviation 14.960
|
11.90 Percent overall class impairment
Standard Deviation 20.154
|
5.56 Percent overall class impairment
Standard Deviation 8.819
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Baseline
|
8.64 Percent overall class impairment
Standard Deviation 14.136
|
10.10 Percent overall class impairment
Standard Deviation 13.237
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 4
|
6.37 Percent overall class impairment
Standard Deviation 14.034
|
7.50 Percent overall class impairment
Standard Deviation 12.701
|
30.69 Percent overall class impairment
Standard Deviation 27.265
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 12
|
15.11 Percent overall class impairment
Standard Deviation 31.477
|
5.28 Percent overall class impairment
Standard Deviation 13.559
|
27.86 Percent overall class impairment
Standard Deviation 24.471
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 16
|
7.78 Percent overall class impairment
Standard Deviation 16.415
|
14.06 Percent overall class impairment
Standard Deviation 24.697
|
24.44 Percent overall class impairment
Standard Deviation 29.707
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 36
|
2.50 Percent overall class impairment
Standard Deviation 5.000
|
2.50 Percent overall class impairment
Standard Deviation 5.000
|
20.00 Percent overall class impairment
Standard Deviation 28.284
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 40
|
2.00 Percent overall class impairment
Standard Deviation 4.472
|
11.79 Percent overall class impairment
Standard Deviation 18.771
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 44
|
10.00 Percent overall class impairment
Standard Deviation 14.142
|
6.67 Percent overall class impairment
Standard Deviation 8.165
|
16.67 Percent overall class impairment
Standard Deviation 5.774
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 48
|
7.50 Percent overall class impairment
Standard Deviation 13.887
|
7.06 Percent overall class impairment
Standard Deviation 12.127
|
17.00 Percent overall class impairment
Standard Deviation 22.804
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=69 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=78 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=88 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 4
|
10.31 Percent activity impairment
Standard Deviation 18.749
|
8.24 Percent activity impairment
Standard Deviation 13.222
|
15.88 Percent activity impairment
Standard Deviation 22.287
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 8
|
8.61 Percent activity impairment
Standard Deviation 13.555
|
7.20 Percent activity impairment
Standard Deviation 12.784
|
16.58 Percent activity impairment
Standard Deviation 23.741
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 12
|
10.31 Percent activity impairment
Standard Deviation 16.749
|
5.31 Percent activity impairment
Standard Deviation 13.087
|
13.44 Percent activity impairment
Standard Deviation 15.368
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 28
|
11.67 Percent activity impairment
Standard Deviation 16.891
|
5.29 Percent activity impairment
Standard Deviation 12.805
|
22.14 Percent activity impairment
Standard Deviation 21.187
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 36
|
11.18 Percent activity impairment
Standard Deviation 15.363
|
9.41 Percent activity impairment
Standard Deviation 13.449
|
7.14 Percent activity impairment
Standard Deviation 9.512
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Baseline
|
8.99 Percent activity impairment
Standard Deviation 15.353
|
10.90 Percent activity impairment
Standard Deviation 16.763
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 16
|
10.00 Percent activity impairment
Standard Deviation 15.927
|
7.12 Percent activity impairment
Standard Deviation 14.731
|
16.19 Percent activity impairment
Standard Deviation 26.168
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 20
|
16.19 Percent activity impairment
Standard Deviation 22.017
|
9.52 Percent activity impairment
Standard Deviation 21.089
|
13.64 Percent activity impairment
Standard Deviation 15.015
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 24
|
8.38 Percent activity impairment
Standard Deviation 13.645
|
5.74 Percent activity impairment
Standard Deviation 12.810
|
16.43 Percent activity impairment
Standard Deviation 19.457
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 32
|
9.12 Percent activity impairment
Standard Deviation 17.815
|
6.89 Percent activity impairment
Standard Deviation 14.744
|
26.92 Percent activity impairment
Standard Deviation 33.760
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 40
|
10.59 Percent activity impairment
Standard Deviation 18.081
|
8.30 Percent activity impairment
Standard Deviation 17.235
|
8.75 Percent activity impairment
Standard Deviation 17.269
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 44
|
13.33 Percent activity impairment
Standard Deviation 21.693
|
7.65 Percent activity impairment
Standard Deviation 16.781
|
16.36 Percent activity impairment
Standard Deviation 21.106
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 48
|
11.00 Percent activity impairment
Standard Deviation 16.263
|
6.05 Percent activity impairment
Standard Deviation 13.997
|
10.00 Percent activity impairment
Standard Deviation 15.954
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Week 52
|
7.50 Percent activity impairment
Standard Deviation 14.368
|
7.21 Percent activity impairment
Standard Deviation 15.480
|
8.00 Percent activity impairment
Standard Deviation 12.649
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5= degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent work time missed due to health problem calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=35 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=38 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 4
|
5.76 Percent work time missed
Standard Deviation 15.662
|
5.54 Percent work time missed
Standard Deviation 15.120
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 8
|
7.50 Percent work time missed
Standard Deviation 16.965
|
3.64 Percent work time missed
Standard Deviation 13.604
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 28
|
0.00 Percent work time missed
Standard Deviation 0.000
|
2.05 Percent work time missed
Standard Deviation 2.899
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 40
|
0.69 Percent work time missed
Standard Deviation 1.814
|
4.95 Percent work time missed
Standard Deviation 15.001
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 52
|
8.33 Percent work time missed
Standard Deviation 20.412
|
3.33 Percent work time missed
Standard Deviation 6.022
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Baseline
|
4.77 Percent work time missed
Standard Deviation 14.528
|
5.07 Percent work time missed
Standard Deviation 14.128
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 12
|
7.14 Percent work time missed
Standard Deviation 18.898
|
5.77 Percent work time missed
Standard Deviation 15.790
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 16
|
23.49 Percent work time missed
Standard Deviation 38.319
|
5.32 Percent work time missed
Standard Deviation 13.142
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 20
|
0.00 Percent work time missed
Standard Deviation 0.000
|
0.73 Percent work time missed
Standard Deviation 1.270
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 24
|
0.34 Percent work time missed
Standard Deviation 0.907
|
8.03 Percent work time missed
Standard Deviation 18.722
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 32
|
11.75 Percent work time missed
Standard Deviation 20.454
|
15.08 Percent work time missed
Standard Deviation 31.936
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 36
|
0.00 Percent work time missed
Standard Deviation 0.000
|
1.40 Percent work time missed
Standard Deviation 2.425
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 44
|
0.00 Percent work time missed
Standard Deviation 0.000
|
1.40 Percent work time missed
Standard Deviation 2.425
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 48
|
1.79 Percent work time missed
Standard Deviation 4.725
|
12.27 Percent work time missed
Standard Deviation 21.541
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100\*Q5/10 score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=35 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=38 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 12
|
5.71 Percent impairment while work
Standard Deviation 7.868
|
12.00 Percent impairment while work
Standard Deviation 24.855
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Baseline
|
9.71 Percent impairment while work
Standard Deviation 15.432
|
10.26 Percent impairment while work
Standard Deviation 17.474
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 4
|
5.00 Percent impairment while work
Standard Deviation 12.693
|
10.56 Percent impairment while work
Standard Deviation 15.136
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 8
|
4.44 Percent impairment while work
Standard Deviation 5.270
|
6.43 Percent impairment while work
Standard Deviation 13.927
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 16
|
8.33 Percent impairment while work
Standard Deviation 11.690
|
7.86 Percent impairment while work
Standard Deviation 17.177
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 20
|
15.00 Percent impairment while work
Standard Deviation 21.213
|
6.67 Percent impairment while work
Standard Deviation 5.774
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 24
|
8.57 Percent impairment while work
Standard Deviation 8.997
|
13.00 Percent impairment while work
Standard Deviation 25.408
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 28
|
10.00 Percent impairment while work
Standard Deviation 14.142
|
0.00 Percent impairment while work
Standard Deviation 0.000
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 32
|
8.33 Percent impairment while work
Standard Deviation 7.528
|
15.00 Percent impairment while work
Standard Deviation 19.003
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 36
|
10.00 Percent impairment while work
Standard Deviation 14.142
|
10.00 Percent impairment while work
Standard Deviation 10.000
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 40
|
12.86 Percent impairment while work
Standard Deviation 11.127
|
14.55 Percent impairment while work
Standard Deviation 23.394
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 44
|
30.00 Percent impairment while work
Standard Deviation 43.589
|
23.33 Percent impairment while work
Standard Deviation 32.146
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 48
|
11.43 Percent impairment while work
Standard Deviation 8.997
|
16.00 Percent impairment while work
Standard Deviation 24.585
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 52
|
8.33 Percent impairment while work
Standard Deviation 7.528
|
15.56 Percent impairment while work
Standard Deviation 25.055
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity: regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]}, score ranged:0-100%, high numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=35 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=38 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 20
|
15.00 Percent overall work impairment
Standard Deviation 21.213
|
7.33 Percent overall work impairment
Standard Deviation 6.429
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Baseline
|
14.04 Percent overall work impairment
Standard Deviation 19.991
|
14.29 Percent overall work impairment
Standard Deviation 21.183
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 4
|
10.74 Percent overall work impairment
Standard Deviation 18.593
|
15.53 Percent overall work impairment
Standard Deviation 20.088
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 8
|
11.77 Percent overall work impairment
Standard Deviation 16.662
|
10.06 Percent overall work impairment
Standard Deviation 18.129
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 12
|
11.43 Percent overall work impairment
Standard Deviation 21.931
|
13.70 Percent overall work impairment
Standard Deviation 27.729
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 16
|
17.57 Percent overall work impairment
Standard Deviation 23.791
|
10.75 Percent overall work impairment
Standard Deviation 22.825
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 24
|
8.86 Percent overall work impairment
Standard Deviation 9.442
|
19.63 Percent overall work impairment
Standard Deviation 29.412
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 28
|
10.00 Percent overall work impairment
Standard Deviation 14.142
|
2.05 Percent overall work impairment
Standard Deviation 2.899
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 32
|
18.92 Percent overall work impairment
Standard Deviation 20.929
|
18.29 Percent overall work impairment
Standard Deviation 24.749
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 36
|
10.00 Percent overall work impairment
Standard Deviation 14.142
|
11.27 Percent overall work impairment
Standard Deviation 10.238
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 40
|
13.40 Percent overall work impairment
Standard Deviation 11.616
|
15.82 Percent overall work impairment
Standard Deviation 26.160
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 44
|
30.00 Percent overall work impairment
Standard Deviation 43.589
|
24.73 Percent overall work impairment
Standard Deviation 30.679
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 48
|
12.86 Percent overall work impairment
Standard Deviation 11.127
|
23.46 Percent overall work impairment
Standard Deviation 29.836
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 52
|
15.83 Percent overall work impairment
Standard Deviation 20.595
|
17.20 Percent overall work impairment
Standard Deviation 25.996
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=29 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=33 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 16
|
0.00 Percent class time missed
Standard Deviation 0.000
|
8.22 Percent class time missed
Standard Deviation 24.416
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 24
|
0.00 Percent class time missed
Standard Deviation 0.000
|
0.71 Percent class time missed
Standard Deviation 2.673
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 40
|
0.00 Percent class time missed
Standard Deviation 0.000
|
0.00 Percent class time missed
Standard Deviation 0.000
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 52
|
0.00 Percent class time missed
Standard Deviation 0.000
|
0.00 Percent class time missed
Standard Deviation 0.000
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Baseline
|
0.04 Percent class time missed
Standard Deviation 0.223
|
2.22 Percent class time missed
Standard Deviation 9.030
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 4
|
0.97 Percent class time missed
Standard Deviation 3.226
|
1.14 Percent class time missed
Standard Deviation 5.330
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 8
|
0.00 Percent class time missed
Standard Deviation 0.000
|
1.62 Percent class time missed
Standard Deviation 6.735
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 12
|
0.00 Percent class time missed
Standard Deviation 0.000
|
3.27 Percent class time missed
Standard Deviation 12.118
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 20
|
0.00 Percent class time missed
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
0.00 Percent class time missed
Standard Deviation 0.000
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 28
|
—
|
0.00 Percent class time missed
Standard Deviation 0.000
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 32
|
0.00 Percent class time missed
Standard Deviation 0.000
|
8.97 Percent class time missed
Standard Deviation 19.226
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 36
|
—
|
0.00 Percent class time missed
Standard Deviation 0.000
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 44
|
0.00 Percent class time missed
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
0.00 Percent class time missed
Standard Deviation 0.000
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 48
|
0.00 Percent class time missed
Standard Deviation 0.000
|
0.00 Percent class time missed
Standard Deviation 0.000
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=29 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=33 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 8
|
1.43 Percent impairment while in class
Standard Deviation 3.780
|
5.79 Percent impairment while in class
Standard Deviation 8.377
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 24
|
10.00 Percent impairment while in class
Standard Deviation 14.142
|
2.86 Percent impairment while in class
Standard Deviation 6.112
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 48
|
7.50 Percent impairment while in class
Standard Deviation 15.000
|
5.56 Percent impairment while in class
Standard Deviation 11.304
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Baseline
|
8.62 Percent impairment while in class
Standard Deviation 14.072
|
7.88 Percent impairment while in class
Standard Deviation 11.390
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 4
|
6.36 Percent impairment while in class
Standard Deviation 12.863
|
6.36 Percent impairment while in class
Standard Deviation 12.168
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 12
|
5.00 Percent impairment while in class
Standard Deviation 10.000
|
2.35 Percent impairment while in class
Standard Deviation 7.524
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 16
|
2.50 Percent impairment while in class
Standard Deviation 5.000
|
8.46 Percent impairment while in class
Standard Deviation 10.682
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 20
|
0.00 Percent impairment while in class
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
14.29 Percent impairment while in class
Standard Deviation 29.921
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 28
|
—
|
10.00 Percent impairment while in class
Standard Deviation 14.142
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 32
|
0.00 Percent impairment while in class
Standard Deviation 0.000
|
3.85 Percent impairment while in class
Standard Deviation 11.209
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 36
|
—
|
5.00 Percent impairment while in class
Standard Deviation 7.071
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 40
|
5.00 Percent impairment while in class
Standard Deviation 7.071
|
6.25 Percent impairment while in class
Standard Deviation 9.161
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 44
|
20.00 Percent impairment while in class
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
10.00 Percent impairment while in class
Standard Deviation 10.000
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 52
|
0.00 Percent impairment while in class
Standard Deviation 0.000
|
3.33 Percent impairment while in class
Standard Deviation 7.071
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]}, score range:0-100%,higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=29 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=33 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Baseline
|
8.64 Percent overall class impairment
Standard Deviation 14.136
|
10.10 Percent overall class impairment
Standard Deviation 13.237
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 4
|
6.95 Percent overall class impairment
Standard Deviation 14.568
|
7.50 Percent overall class impairment
Standard Deviation 12.701
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 8
|
1.43 Percent overall class impairment
Standard Deviation 3.780
|
7.40 Percent overall class impairment
Standard Deviation 9.858
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 12
|
5.00 Percent overall class impairment
Standard Deviation 10.000
|
5.59 Percent overall class impairment
Standard Deviation 13.910
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 16
|
2.50 Percent overall class impairment
Standard Deviation 5.000
|
14.37 Percent overall class impairment
Standard Deviation 25.677
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 20
|
0.00 Percent overall class impairment
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
14.29 Percent overall class impairment
Standard Deviation 29.921
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 24
|
10.00 Percent overall class impairment
Standard Deviation 14.142
|
3.50 Percent overall class impairment
Standard Deviation 7.283
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 28
|
—
|
10.00 Percent overall class impairment
Standard Deviation 14.142
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 32
|
0.00 Percent overall class impairment
Standard Deviation 0.000
|
12.39 Percent overall class impairment
Standard Deviation 21.847
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 36
|
—
|
5.00 Percent overall class impairment
Standard Deviation 7.071
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 40
|
5.00 Percent overall class impairment
Standard Deviation 7.071
|
6.25 Percent overall class impairment
Standard Deviation 9.161
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 44
|
20.00 Percent overall class impairment
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
10.00 Percent overall class impairment
Standard Deviation 10.000
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 48
|
7.50 Percent overall class impairment
Standard Deviation 15.000
|
5.56 Percent overall class impairment
Standard Deviation 11.304
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 52
|
0.00 Percent overall class impairment
Standard Deviation 0.000
|
3.33 Percent overall class impairment
Standard Deviation 7.071
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=69 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=78 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Baseline
|
8.99 Percent activity impairment
Standard Deviation 15.353
|
10.90 Percent activity impairment
Standard Deviation 16.763
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 4
|
11.00 Percent activity impairment
Standard Deviation 19.182
|
8.24 Percent activity impairment
Standard Deviation 13.222
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 8
|
10.00 Percent activity impairment
Standard Deviation 15.275
|
7.27 Percent activity impairment
Standard Deviation 13.005
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 12
|
10.50 Percent activity impairment
Standard Deviation 18.202
|
5.50 Percent activity impairment
Standard Deviation 13.765
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 24
|
8.24 Percent activity impairment
Standard Deviation 13.339
|
5.81 Percent activity impairment
Standard Deviation 13.850
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 16
|
8.95 Percent activity impairment
Standard Deviation 15.949
|
8.11 Percent activity impairment
Standard Deviation 15.958
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 20
|
15.00 Percent activity impairment
Standard Deviation 16.903
|
9.23 Percent activity impairment
Standard Deviation 22.159
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 28
|
17.14 Percent activity impairment
Standard Deviation 17.995
|
3.33 Percent activity impairment
Standard Deviation 7.071
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 32
|
11.88 Percent activity impairment
Standard Deviation 22.574
|
8.52 Percent activity impairment
Standard Deviation 17.255
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 36
|
15.00 Percent activity impairment
Standard Deviation 13.784
|
8.57 Percent activity impairment
Standard Deviation 8.997
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 40
|
12.35 Percent activity impairment
Standard Deviation 17.864
|
7.31 Percent activity impairment
Standard Deviation 16.385
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 44
|
15.71 Percent activity impairment
Standard Deviation 17.182
|
8.89 Percent activity impairment
Standard Deviation 16.915
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 48
|
11.18 Percent activity impairment
Standard Deviation 16.539
|
7.50 Percent activity impairment
Standard Deviation 16.485
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Week 52
|
12.00 Percent activity impairment
Standard Deviation 17.403
|
6.52 Percent activity impairment
Standard Deviation 16.951
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores=less productivity). Percent work time missed due to health problem calculated as: Q2\*100/(Q2+Q4) and score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=19 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=15 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 0
|
5.46 Percent work time missed
Standard Deviation 14.226
|
6.99 Percent work time missed
Standard Deviation 18.460
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 8
|
2.36 Percent work time missed
Standard Deviation 5.277
|
0.00 Percent work time missed
Standard Deviation 0.000
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 4
|
1.49 Percent work time missed
Standard Deviation 3.188
|
0.00 Percent work time missed
Standard Deviation 0.000
|
—
|
|
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 12
|
34.40 Percent work time missed
Standard Deviation 48.649
|
0.00 Percent work time missed
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100\*Q5/10 score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=19 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=15 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 4
|
12.00 Percent impairment while work
Standard Deviation 18.738
|
10.00 Percent impairment while work
Standard Deviation 10.000
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 0
|
11.05 Percent impairment while work
Standard Deviation 14.868
|
16.67 Percent impairment while work
Standard Deviation 31.547
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 8
|
8.00 Percent impairment while work
Standard Deviation 17.889
|
15.00 Percent impairment while work
Standard Deviation 21.213
|
—
|
|
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 12
|
50.00 Percent impairment while work
Standard Deviation 14.142
|
0.00 Percent impairment while work
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100\*{Q2/(Q2+Q4)+\[(1- Q2/(Q2+Q4))×(Q5/10)\]}, score ranged:0-100%, high numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=19 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=15 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 0
|
16.21 Percent overall work impairment
Standard Deviation 18.311
|
20.32 Percent overall work impairment
Standard Deviation 32.634
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 4
|
13.40 Percent overall work impairment
Standard Deviation 18.431
|
10.00 Percent overall work impairment
Standard Deviation 10.000
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 8
|
10.36 Percent overall work impairment
Standard Deviation 17.339
|
15.00 Percent overall work impairment
Standard Deviation 21.213
|
—
|
|
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 12
|
70.65 Percent overall work impairment
Standard Deviation 15.061
|
0.00 Percent overall work impairment
Standard Deviation NA
Standard deviation could not be estimated due to less number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7\*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=13 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=16 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 8
|
0.00 Percent class time missed
Standard Deviation 0.000
|
8.33 Percent class time missed
Standard Deviation 20.412
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 0
|
3.98 Percent class time missed
Standard Deviation 12.314
|
11.53 Percent class time missed
Standard Deviation 27.668
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 4
|
0.00 Percent class time missed
Standard Deviation 0.000
|
6.82 Percent class time missed
Standard Deviation 16.215
|
—
|
|
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 12
|
—
|
1.43 Percent class time missed
Standard Deviation 2.850
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100\*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=13 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=15 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 8
|
30.00 Percent impairment while in class
Standard Deviation 14.142
|
30.00 Percent impairment while in class
Standard Deviation 26.077
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 0
|
13.85 Percent impairment while in class
Standard Deviation 17.578
|
24.67 Percent impairment while in class
Standard Deviation 28.999
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 4
|
16.67 Percent impairment while in class
Standard Deviation 13.663
|
25.00 Percent impairment while in class
Standard Deviation 25.761
|
—
|
|
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 12
|
—
|
40.00 Percent impairment while in class
Standard Deviation 28.284
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100\*{Q7/(Q7+Q8)+\[(1- Q7/(Q7+Q8))×(Q9/10)\]}, score range:0-100%, higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=13 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=15 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 0
|
17.49 Percent overall class impairment
Standard Deviation 19.742
|
25.60 Percent overall class impairment
Standard Deviation 30.354
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 4
|
16.67 Percent overall class impairment
Standard Deviation 13.663
|
30.21 Percent overall class impairment
Standard Deviation 26.983
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 8
|
30.00 Percent overall class impairment
Standard Deviation 14.142
|
34.17 Percent overall class impairment
Standard Deviation 31.371
|
—
|
|
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 12
|
—
|
40.28 Percent overall class impairment
Standard Deviation 28.803
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100\*Q10/10, scores ranged from 0-100%,higher numbers=greater impairment and less productivity.
Outcome measures
| Measure |
Vehicle QD
n=43 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=44 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 0
|
14.88 Percent activity impairment
Standard Deviation 20.745
|
17.27 Percent activity impairment
Standard Deviation 23.164
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 4
|
15.24 Percent activity impairment
Standard Deviation 20.401
|
19.17 Percent activity impairment
Standard Deviation 21.653
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 8
|
13.85 Percent activity impairment
Standard Deviation 17.578
|
26.00 Percent activity impairment
Standard Deviation 28.486
|
—
|
|
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Week 12
|
16.67 Percent activity impairment
Standard Deviation 20.817
|
31.43 Percent activity impairment
Standard Deviation 29.681
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8Population: Eval-OL population included all participants that received at least 1 dose of study intervention in the OL period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-anxiety (HADS-A) and HADS-depression (HADS-D), each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Outcome measures
| Measure |
Vehicle QD
n=270 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Anxiety: Baseline
|
5.3 Units on a scale
Standard Deviation 3.70 • Interval 3.7 to
|
—
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Anxiety: Week 2
|
5.3 Units on a scale
Standard Deviation 3.73 • Interval 3.73 to
|
—
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Anxiety: Week 4
|
5.3 Units on a scale
Standard Deviation 3.72 • Interval 3.72 to
|
—
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Anxiety: Week 6
|
5.4 Units on a scale
Standard Deviation 3.79 • Interval 3.79 to
|
—
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Anxiety: Week 8
|
5.4 Units on a scale
Standard Deviation 3.81 • Interval 3.81 to
|
—
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Depression: Baseline
|
3.2 Units on a scale
Standard Deviation 3.09 • Interval 3.09 to
|
—
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Depression: Week 2
|
3.2 Units on a scale
Standard Deviation 3.09 • Interval 3.09 to
|
—
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Depression: Week 4
|
3.2 Units on a scale
Standard Deviation 3.11 • Interval 3.11 to
|
—
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Depression: Week 6
|
3.3 Units on a scale
Standard Deviation 3.16 • Interval 3.16 to
|
—
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Depression: Week 8
|
3.3 Units on a scale
Standard Deviation 3.21 • Interval 3.21 to
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including randomization day), Week 8, 16, 32 and end of treatment [Week 52]Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Outcome measures
| Measure |
Vehicle QD
n=66 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=77 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
n=25 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Anxiety: Baseline
|
4.5 Units on a scale
Standard Deviation 3.50
|
4.5 Units on a scale
Standard Deviation 3.59
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Depression: End of treatment
|
2.8 Units on a scale
Standard Deviation 2.77
|
3.4 Units on a scale
Standard Deviation 3.23
|
2.6 Units on a scale
Standard Deviation 2.91
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Anxiety: Week 8
|
3.6 Units on a scale
Standard Deviation 3.23
|
4.5 Units on a scale
Standard Deviation 3.09
|
3.8 Units on a scale
Standard Deviation 2.71
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Anxiety: Week 16
|
4.6 Units on a scale
Standard Deviation 3.83
|
4.7 Units on a scale
Standard Deviation 3.58
|
3.0 Units on a scale
Standard Deviation 2.65
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Anxiety: Week 32
|
3.3 Units on a scale
Standard Deviation 3.42
|
4.4 Units on a scale
Standard Deviation 4.00
|
4.0 Units on a scale
Standard Deviation 5.66
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Anxiety: End of treatment
|
4.0 Units on a scale
Standard Deviation 3.95
|
4.7 Units on a scale
Standard Deviation 3.62
|
4.7 Units on a scale
Standard Deviation 2.91
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Depression: Baseline
|
2.7 Units on a scale
Standard Deviation 2.36
|
2.8 Units on a scale
Standard Deviation 2.94
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Depression: Week 8
|
2.1 Units on a scale
Standard Deviation 2.00
|
2.5 Units on a scale
Standard Deviation 2.65
|
2.2 Units on a scale
Standard Deviation 1.72
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Depression: Week 16
|
2.9 Units on a scale
Standard Deviation 2.65
|
3.5 Units on a scale
Standard Deviation 3.76
|
1.3 Units on a scale
Standard Deviation 1.53
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Depression: Week 32
|
2.6 Units on a scale
Standard Deviation 2.82
|
3.3 Units on a scale
Standard Deviation 3.76
|
3.5 Units on a scale
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8 and 12Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Outcome measures
| Measure |
Vehicle QD
n=15 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=18 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
Anxiety: Week 0
|
3.7 Units on a scale
Standard Deviation 3.52
|
4.9 Units on a scale
Standard Deviation 3.70
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
Anxiety: Week 4
|
4.3 Units on a scale
Standard Deviation 3.46
|
5.8 Units on a scale
Standard Deviation 4.19
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
Anxiety: Week 8
|
4.3 Units on a scale
Standard Deviation 1.89
|
8.0 Units on a scale
Standard Deviation 5.24
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
Anxiety: Week 12
|
6.0 Units on a scale
Standard Deviation 1.00
|
5.0 Units on a scale
Standard Deviation 4.73
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
Depression: Week 0
|
2.4 Units on a scale
Standard Deviation 3.07
|
2.5 Units on a scale
Standard Deviation 3.16
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
Depression: Week 4
|
3.1 Units on a scale
Standard Deviation 2.79
|
4.2 Units on a scale
Standard Deviation 5.19
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
Depression: Week 8
|
1.3 Units on a scale
Standard Deviation 1.26
|
4.8 Units on a scale
Standard Deviation 4.44
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
Depression: Week 12
|
1.0 Units on a scale
Standard Deviation 1.00
|
3.3 Units on a scale
Standard Deviation 2.16
|
—
|
SECONDARY outcome
Timeframe: Baseline (last observation up to and including the randomization day of DB period), Weeks 8, 16 and 32Population: Eval-DB population included all randomized participants with success in ISGA and EASI50 criteria as responders at randomization and received at least 1 dose of study intervention in the DB period. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specified time points.
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Outcome measures
| Measure |
Vehicle QD
n=66 Participants
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. Participants who developed flares during the DB maintenance period were switched to receive crisaborole 2% ointment BID in an open-label manner until resumption of DB treatment with vehicle.
|
Crisaborole 2% QD
n=77 Participants
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
Crisaborole 2% QD
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If any participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
|---|---|---|---|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
Anxiety: Week 8
|
3.8 Units on a scale
Standard Deviation 3.28
|
4.1 Units on a scale
Standard Deviation 2.74
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
Anxiety: Baseline
|
4.5 Units on a scale
Standard Deviation 3.50
|
4.5 Units on a scale
Standard Deviation 3.59
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
Anxiety: Week 16
|
3.9 Units on a scale
Standard Deviation 3.38
|
4.3 Units on a scale
Standard Deviation 3.49
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
Anxiety: Week 32
|
2.9 Units on a scale
Standard Deviation 2.47
|
4.2 Units on a scale
Standard Deviation 3.79
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
Depression: Baseline
|
2.7 Units on a scale
Standard Deviation 2.36
|
2.8 Units on a scale
Standard Deviation 2.94
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
Depression: Week 8
|
2.2 Units on a scale
Standard Deviation 2.13
|
2.2 Units on a scale
Standard Deviation 2.29
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
Depression: Week 16
|
2.1 Units on a scale
Standard Deviation 1.91
|
3.1 Units on a scale
Standard Deviation 3.46
|
—
|
|
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
Depression: Week 32
|
1.9 Units on a scale
Standard Deviation 2.22
|
3.0 Units on a scale
Standard Deviation 3.00
|
—
|
Adverse Events
OL: Crisaborole 2% BID
Serious events: 3 serious events
Other events: 78 other events
Deaths: 0 deaths
DB: Vehicle
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
DB: Crisaborole 2% QD
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
DB Flare: Vehicle
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
DB Flare: Crisaborole 2% QD
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OL: Crisaborole 2% BID
n=497 participants at risk
Participants with mild to moderate AD were administered crisaborole 2% ointment applied topically BID for maximum duration of up to 8 weeks in OL run-in period
|
DB: Vehicle
n=135 participants at risk
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. If a participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with vehicle was resumed.
|
DB: Crisaborole 2% QD
n=135 participants at risk
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If a participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
DB Flare: Vehicle
n=89 participants at risk
Participants with an onset of flare (ISGA\>=2) during DB maintenance period were switched to receive open-label crisaborole ointment 2%BID for up to 12 weeks until resolution of flares and resumption of DB maintenance treatment.
|
DB Flare: Crisaborole 2% QD
n=78 participants at risk
Participants with an onset of flare (ISGA\>=2) during DB maintenance period were switched to receive open-label crisaborole ointment 2% BID for up to 12 weeks until resolution of flares and resumption of DB maintenance treatment.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Application site infection
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Skin infection
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Foreign body ingestion
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Maternal exposure during pregnancy
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Paternal exposure during pregnancy
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
Other adverse events
| Measure |
OL: Crisaborole 2% BID
n=497 participants at risk
Participants with mild to moderate AD were administered crisaborole 2% ointment applied topically BID for maximum duration of up to 8 weeks in OL run-in period
|
DB: Vehicle
n=135 participants at risk
Participants identified as responders during the OL period were randomized to receive vehicle applied topically QD for 52 weeks in the DB maintenance period. If a participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with vehicle was resumed.
|
DB: Crisaborole 2% QD
n=135 participants at risk
Participants identified as responders during the OL period were randomized to receive crisaborole 2% ointment applied topically QD for 52 weeks in the DB maintenance period. If a participant developed flares during the DB maintenance period, the participant was switched to receive flare rescue treatment with crisaborole 2% ointment BID in an open-label manner until resolution of flares following which DB treatment with crisaborole 2% QD was resumed.
|
DB Flare: Vehicle
n=89 participants at risk
Participants with an onset of flare (ISGA\>=2) during DB maintenance period were switched to receive open-label crisaborole ointment 2%BID for up to 12 weeks until resolution of flares and resumption of DB maintenance treatment.
|
DB Flare: Crisaborole 2% QD
n=78 participants at risk
Participants with an onset of flare (ISGA\>=2) during DB maintenance period were switched to receive open-label crisaborole ointment 2% BID for up to 12 weeks until resolution of flares and resumption of DB maintenance treatment.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
General disorders
Application site erythema
|
1.0%
5/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
General disorders
Application site pain
|
5.6%
28/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
General disorders
Application site pruritus
|
1.0%
5/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
General disorders
Pyrexia
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Immune system disorders
Allergy to animal
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Application site infection
|
1.2%
6/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
3.4%
3/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Bronchitis
|
0.40%
2/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.2%
3/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
3.7%
5/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Conjunctivitis
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Influenza
|
0.80%
4/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.2%
3/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.80%
4/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
3.7%
5/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Otitis media
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
10/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
3.0%
4/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Viral infection
|
0.40%
2/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.2%
3/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.2%
3/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.2%
2/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.2%
2/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.2%
2/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.4%
12/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.2%
3/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.2%
2/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.6%
2/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.80%
4/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
2/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.2%
2/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.80%
4/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
General disorders
Application site acne
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
General disorders
Developmental delay
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Immune system disorders
Food allergy
|
0.60%
3/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Application site cellulitis
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Sinusitis
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Ear infection
|
0.40%
2/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.74%
1/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Radial head dislocation
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.20%
1/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
1/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/497 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/135 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
1/89 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/78 • From start of study intervention up to 8 weeks of OL period (OL: Crisaborole 2% BID arm); From start of study intervention in DB period to 28 days after last dose of study intervention (Up to 56 weeks) for DB: vehicle QD and DB: Crisaborole 2% QD arms
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER