Trial Outcomes & Findings for Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis (NCT NCT04360187)
NCT ID: NCT04360187
Last Updated: 2022-06-07
Results Overview
An adverse event was considered as a treatment-emergent adverse event (TEAE) if the event started after the first dose of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
COMPLETED
PHASE3
391 participants
Baseline up to Day 60
2022-06-07
Participant Flow
Participant milestones
| Measure |
Vehicle Twice a Day (BID)
Vehicle was applied BID for 28 days to the Treatable body surface area (BSA) identified at Baseline/Day 1 and new atopic dermatitis (AD) lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Double-Blind Treatment
STARTED
|
131
|
260
|
|
Double-Blind Treatment
COMPLETED
|
108
|
245
|
|
Double-Blind Treatment
NOT COMPLETED
|
23
|
15
|
|
Follow-Up
STARTED
|
114
|
232
|
|
Follow-Up
COMPLETED
|
113
|
232
|
|
Follow-Up
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Vehicle Twice a Day (BID)
Vehicle was applied BID for 28 days to the Treatable body surface area (BSA) identified at Baseline/Day 1 and new atopic dermatitis (AD) lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Double-Blind Treatment
Adverse Event
|
9
|
11
|
|
Double-Blind Treatment
Lack of Efficacy
|
7
|
2
|
|
Double-Blind Treatment
Physician Decision
|
1
|
0
|
|
Double-Blind Treatment
Withdrawal by Subject
|
4
|
2
|
|
Double-Blind Treatment
Withdrawal By Parent/Guardian
|
2
|
0
|
|
Follow-Up
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Total
n=391 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2-11 Years
|
69 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Age, Customized
12-17 Years
|
15 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Customized
>=18 Years
|
47 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
131 Participants
n=5 Participants
|
260 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
131 Participants
n=5 Participants
|
260 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received.
The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29
|
-42.79 Percent Change
Interval -50.14 to -35.44
|
-59.92 Percent Change
Interval -64.86 to -54.98
|
PRIMARY outcome
Timeframe: Baseline up to Day 60Population: Overall number of participants analyzed included all participants who were randomized and received at least 1 confirmed dose of investigational product.
An adverse event was considered as a treatment-emergent adverse event (TEAE) if the event started after the first dose of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Participants With Serious Adverse Events
|
0.8 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Participants With Severe Adverse Events
|
1.5 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Participants Discontinued From Study Due to Adverse Events
|
0.8 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Participants With Adverse Events
|
44.3 Percentage of Participants
|
46.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 29Population: The Safety Analysis Set included all participants who were randomized and received at least 1 confirmed dose of investigational product. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for each row.
Laboratory parameters included: hematology and chemistry. Clinically significant laboratory abnormalities are defined as abnormal values that have clinical manifestations or require medical intervention. Clinically significant laboratory criteria included Hemoglobin \<0.8 x lower limit of normal (LLN), Leukocytes \>1.5 x upper limit of normal (ULN), Lymphocytes \<0.8 x LLN, Lymphocytes/Leukocytes \>1.2 x ULN, Neutrophils \<0.8 x LLN, Neutrophils \>1.2x ULN, Neutrophils/Leukocytes \<0.8 x LLN, Basophils/Leukocytes \>1.2 x ULN, Eosinophils \>1.2 x ULN, Eosinophils/Leukocytes \>1.2 x ULN, Monocytes \>1.2 x ULN, Monocytes/Leukocytes (%) \>1.2 x ULN, Bicarbonate \<0.9 x LLN, and Glucose \>1.5x ULN.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=126 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=258 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Hemoglobin (g/L) <0.8 x lower limit of normal (LLN)
|
1.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Leukocytes (10^9/L) >1.5 x upper limit of normal (ULN)
|
0 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Lymphocytes (10^9/L) <0.8 x LLN
|
0.8 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Lymphocytes/Leukocytes (%) >1.2 x ULN
|
3.2 Percentage of Participants
|
1.9 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Neutrophils (10^9/L) <0.8 x LLN
|
0 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Neutrophils (10^9/L) >1.2 x ULN
|
0 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Neutrophils/Leukocytes (%) <0.8 x LLN
|
3.2 Percentage of Participants
|
2.7 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Basophils/Leukocytes (%) >1.2 x ULN
|
4.8 Percentage of Participants
|
3.1 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Eosinophils (10^9/L) >1.2 x ULN
|
33.1 Percentage of Participants
|
31.1 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Monocytes (10^9/L) >1.2 x ULN
|
0 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Monocytes/Leukocytes (%) >1.2 x ULN
|
1.6 Percentage of Participants
|
1.6 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Bicarbonate (mmol/L) <0.9 x LLN
|
0.8 Percentage of Participants
|
0.8 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Glucose (mmol/L) >1.5 x ULN
|
0 Percentage of Participants
|
0.8 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Eosinophils/Leukocytes (%) >1.2 x ULN
|
29.8 Percentage of Participants
|
33.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 29Population: The Safety Analysis Set included all participants who were randomized and received at least 1 confirmed dose of investigational product. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure for each row.
Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participants in the seated position, after having sat/lied calmly for at least 5 minutes. Clinically significant vital signs criteria included Diastolic Blood Pressure (DBP) Value \<50 mmHg, DBP Change ≥20 mmHg increase, DBP Change ≥20 mmHg decrease, Pulse Rate Value \>120 beats per minute (bpm), Systolic Blood Pressure (SBP) Value \<90 mmHg, SBP Change ≥30 mmHg increase, SBP Change ≥30mmHg decrease
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=129 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=259 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Diastolic Blood Pressure (mmHg) Value <50 mmHg
|
7.8 Percentage of Participants
|
7.3 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Diastolic Blood Pressure (mmHg) Change ≥20mmHg increase
|
2.3 Percentage of Participants
|
3.5 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Diastolic Blood Pressure (mmHg) Change ≥20mmHg decrease
|
3.9 Percentage of Participants
|
3.1 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Pulse Rate (bpm) Value >120 beats per minute (bpm)
|
2.3 Percentage of Participants
|
1.9 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Systolic Blood Pressure (mmHg) Value <90mmHg
|
23.3 Percentage of Participants
|
26.3 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Systolic Blood Pressure (mmHg) Change ≥30mmHg increase
|
0 Percentage of Participants
|
2.3 Percentage of Participants
|
|
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Systolic Blood Pressure (mmHg) Change ≥30mmHg decrease
|
3.1 Percentage of Participants
|
0.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received.
ISGA assessed the severity of atopic dermatitis (AD) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Improvement in ISGA is defined as ISGA score of 0 or 1.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29
|
28.5 Percentage of Participants
Interval 20.4 to 36.6
|
41.4 Percentage of Participants
Interval 35.4 to 47.5
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received.
ISGA assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Success in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percentage of Participants Achieving Success in ISGA at Day 29
|
15.9 Percentage of Participants
Interval 9.4 to 22.5
|
27.6 Percentage of Participants
Interval 22.1 to 33.1
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received.
Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 is no pruritus and 10 is worst itch imaginable. Change: score at Week 4 minus score at baseline.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=62 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=137 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years
|
-0.79 Units on a Scale
Interval -1.18 to -0.4
|
-1.58 Units on a Scale
Interval -1.84 to -1.33
|
SECONDARY outcome
Timeframe: Baseline, Day 8, Day 15, Day 22, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
ISGA assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Success in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percentage of Participants Achieving Success in ISGA Over Time
Day 22
|
10.8 Percentage of Participants
Interval 5.2 to 16.3
|
18.1 Percentage of Participants
Interval 13.4 to 22.8
|
|
Percentage of Participants Achieving Success in ISGA Over Time
Day 8
|
0.0 Percentage of Participants
Interval -0.2 to 0.2
|
4.8 Percentage of Participants
Interval 2.2 to 7.4
|
|
Percentage of Participants Achieving Success in ISGA Over Time
Day 15
|
4.9 Percentage of Participants
Interval 1.1 to 8.7
|
11.6 Percentage of Participants
Interval 7.6 to 15.6
|
|
Percentage of Participants Achieving Success in ISGA Over Time
Day 29
|
15.9 Percentage of Participants
Interval 9.4 to 22.5
|
27.6 Percentage of Participants
Interval 22.1 to 33.1
|
SECONDARY outcome
Timeframe: Baseline, Day 8, Day 15, Day 22, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
ISGA (Investigator's Static Global Assessment) assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Improvement in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) .
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percentage of Participants Achieving Improvement in ISGA Over Time
Day 8
|
7.8 Percentage of Participants
Interval 3.2 to 12.4
|
16.8 Percentage of Participants
Interval 12.3 to 21.4
|
|
Percentage of Participants Achieving Improvement in ISGA Over Time
Day 29
|
28.5 Percentage of Participants
Interval 20.4 to 36.6
|
41.4 Percentage of Participants
Interval 35.4 to 47.5
|
|
Percentage of Participants Achieving Improvement in ISGA Over Time
Day 15
|
18.3 Percentage of Participants
Interval 11.6 to 25.1
|
25.6 Percentage of Participants
Interval 20.2 to 31.0
|
|
Percentage of Participants Achieving Improvement in ISGA Over Time
Day 22
|
25.1 Percentage of Participants
Interval 17.4 to 32.7
|
32.3 Percentage of Participants
Interval 26.6 to 38.1
|
SECONDARY outcome
Timeframe: Baseline, Day 8, Day 15, Day 22, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percent Change From Baseline in EASI Total Score Over Time
Day 8
|
-21.43 Percent Change
Interval -28.43 to -14.44
|
-36.65 Percent Change
Interval -41.52 to -31.78
|
|
Percent Change From Baseline in EASI Total Score Over Time
Day 15
|
-37.15 Percent Change
Interval -44.24 to -30.05
|
-49.65 Percent Change
Interval -54.53 to -44.76
|
|
Percent Change From Baseline in EASI Total Score Over Time
Day 29
|
-42.79 Percent Change
Interval -50.14 to -35.44
|
-59.92 Percent Change
Interval -64.86 to -54.98
|
|
Percent Change From Baseline in EASI Total Score Over Time
Day 22
|
-42.92 Percent Change
Interval -50.16 to -35.69
|
-55.05 Percent Change
Interval -59.96 to -50.13
|
SECONDARY outcome
Timeframe: Baseline, Day 8, Day 15, Day 22, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp was excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Percent Body Surface Area (%BSA) Over Time
Day 15
|
-3.31 Percentage BSA
Interval -4.94 to -1.68
|
-7.60 Percentage BSA
Interval -8.75 to -6.46
|
|
Change From Baseline in Percent Body Surface Area (%BSA) Over Time
Day 8
|
-1.75 Percentage BSA
Interval -3.37 to -0.13
|
-5.12 Percentage BSA
Interval -6.26 to -3.98
|
|
Change From Baseline in Percent Body Surface Area (%BSA) Over Time
Day 22
|
-4.38 Percentage BSA
Interval -6.04 to -2.71
|
-8.72 Percentage BSA
Interval -9.87 to -7.57
|
|
Change From Baseline in Percent Body Surface Area (%BSA) Over Time
Day 29
|
-4.81 Percentage BSA
Interval -6.5 to -3.11
|
-9.89 Percentage BSA
Interval -11.05 to -8.73
|
SECONDARY outcome
Timeframe: Baseline, Day 8, Day 15, Day 22, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. EASI-50 is defined as EASI score has ≥50% improvement from baseline.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percentage of Participants Achieving EASI-50 Over Time
Day 8
|
18.5 Percentage of Participants
Interval 11.8 to 25.1
|
37.1 Percentage of Participants
Interval 31.2 to 43.0
|
|
Percentage of Participants Achieving EASI-50 Over Time
Day 15
|
32.7 Percentage of Participants
Interval 24.5 to 40.8
|
58.9 Percentage of Participants
Interval 52.9 to 65.0
|
|
Percentage of Participants Achieving EASI-50 Over Time
Day 22
|
42.2 Percentage of Participants
Interval 33.5 to 50.9
|
66.4 Percentage of Participants
Interval 60.7 to 72.2
|
|
Percentage of Participants Achieving EASI-50 Over Time
Day 29
|
49.4 Percentage of Participants
Interval 40.5 to 58.2
|
72.7 Percentage of Participants
Interval 67.3 to 78.2
|
SECONDARY outcome
Timeframe: Baseline, Day 8, Day 15, Day 22, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. EASI-75 is defined as EASI score has ≥75% improvement from baseline.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=131 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Percentage of Participants Achieving EASI-75 Over Time
Day 8
|
6.1 Percentage of Participants
Interval 2.0 to 10.2
|
11.2 Percentage of Participants
Interval 7.4 to 15.0
|
|
Percentage of Participants Achieving EASI-75 Over Time
Day 22
|
26.3 Percentage of Participants
Interval 18.6 to 34.0
|
38.2 Percentage of Participants
Interval 32.2 to 44.1
|
|
Percentage of Participants Achieving EASI-75 Over Time
Day 29
|
27.6 Percentage of Participants
Interval 19.8 to 35.4
|
46.4 Percentage of Participants
Interval 40.3 to 52.5
|
|
Percentage of Participants Achieving EASI-75 Over Time
Day 15
|
15.4 Percentage of Participants
Interval 9.2 to 21.6
|
26.3 Percentage of Participants
Interval 20.9 to 31.7
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Peak Pruritus NRS is participants-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 is no pruritus and 10 is worst itch imaginable. Change: score at observation minus score at baseline.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=62 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=137 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years
Week 1
|
-0.38 Units on a Scale
Interval -0.75 to -0.01
|
-0.94 Units on a Scale
Interval -1.19 to -0.69
|
|
Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years
Week 2
|
-0.53 Units on a Scale
Interval -0.9 to -0.15
|
-1.26 Units on a Scale
Interval -1.52 to -1.01
|
|
Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years
Week 3
|
-0.64 Units on a Scale
Interval -1.02 to -0.26
|
-1.41 Units on a Scale
Interval -1.66 to -1.16
|
|
Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years
Week 4
|
-0.79 Units on a Scale
Interval -1.18 to -0.4
|
-1.58 Units on a Scale
Interval -1.84 to -1.33
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥ 6 and \<12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Patient Reported Itch Severity Scale is a 5-point scale indicating no itchy to very itchy (ranged from 0 to 4, where 0=no itch to 4=worst itch imaginable) for participants ≥6 and \<12 years of age.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=36 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=81 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years
Week 1
|
-0.26 Units on a Scale
Interval -0.47 to -0.05
|
-0.51 Units on a Scale
Interval -0.66 to -0.36
|
|
Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years
Week 2
|
-0.22 Units on a Scale
Interval -0.43 to -0.01
|
-0.70 Units on a Scale
Interval -0.85 to -0.55
|
|
Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years
Week 3
|
-0.37 Units on a Scale
Interval -0.59 to -0.16
|
-0.78 Units on a Scale
Interval -0.92 to -0.63
|
|
Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years
Week 4
|
-0.52 Units on a Scale
Interval -0.74 to -0.3
|
-0.86 Units on a Scale
Interval -1.0 to -0.71
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged \<6 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
Observer Reported Itch Severity Scale is an 11-point (ranged from 0 to 10, where 0=no itch to 10=worst itch imaginable) scale and must be completed by the observer (caregivers of participants) for participants \<6 years of age.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=33 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=42 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years
Week 2
|
-0.73 Units on a Scale
Interval -1.22 to -0.24
|
-1.68 Units on a Scale
Interval -2.1 to -1.27
|
|
Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years
Week 1
|
-0.31 Units on a Scale
Interval -0.8 to 0.17
|
-1.03 Units on a Scale
Interval -1.44 to -0.62
|
|
Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years
Week 3
|
-0.96 Units on a Scale
Interval -1.46 to -0.47
|
-1.79 Units on a Scale
Interval -2.21 to -1.38
|
|
Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years
Week 4
|
-1.25 Units on a Scale
Interval -1.75 to -0.75
|
-1.95 Units on a Scale
Interval -2.37 to -1.53
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥16 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. The questionnaire will be completed by all participants aged 16 years and older, based on the age at Screening Visit/time of informed consent/assent. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=49 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=117 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
Day 15
|
-1.1 Units on a Scale
Standard Deviation 4.02
|
-1.7 Units on a Scale
Standard Deviation 3.57
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
Day 29
|
-1.5 Units on a Scale
Standard Deviation 4.67
|
-1.8 Units on a Scale
Standard Deviation 4.11
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged 4-15 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children's (aged 4-15 years) quality of life. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=67 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=127 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time
Day 15
|
-1.3 Units on a Scale
Standard Deviation 5.18
|
-3.6 Units on a Scale
Standard Deviation 4.64
|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time
Day 29
|
-1.8 Units on a Scale
Standard Deviation 6.00
|
-3.9 Units on a Scale
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged 2-3 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The IDQOL was completed by observer for participants aged 2-3 years, based on the age at the Screening Visit/time of informed consent/assent. The IDQOL is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score the more quality of life is impaired.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=15 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=16 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time
Day 15
|
-1.3 Units on a Scale
Standard Deviation 3.34
|
-3.0 Units on a Scale
Standard Deviation 3.30
|
|
Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time
Day 29
|
-0.7 Units on a Scale
Standard Deviation 3.86
|
-4.3 Units on a Scale
Standard Deviation 4.44
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged 2-17 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The DFI was completed by all observer for participants aged 2-17 years, based on the age at Screening Visit/time of informed consent/assent. The minimum DFI score is 0; the maximum DFI score is 30. The higher score means worse outcome.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=84 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=148 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time
Day 15
|
-0.5 Units on a Scale
Standard Deviation 3.87
|
-2.4 Units on a Scale
Standard Deviation 4.66
|
|
Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time
Day 29
|
-2.1 Units on a Scale
Standard Deviation 4.86
|
-3.0 Units on a Scale
Standard Deviation 5.22
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The POEM is a validated 7-item measure used to assess the impact of AD over the past week. The POEM contains 7 symptom based questions with responses rating number of days each symptom is experienced over the past week, from 0 (no days) to 4 (every day), with a maximum score of 28. Higher score means worse outcome.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=62 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=137 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years
Day 15
|
-1.8 Units on a Scale
Standard Deviation 5.25
|
-5.4 Units on a Scale
Standard Deviation 5.19
|
|
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years
Day 29
|
-3.3 Units on a Scale
Standard Deviation 5.38
|
-5.7 Units on a Scale
Standard Deviation 6.32
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥2 and \<12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The POEM is a validated 7-item measure used to assess the impact of AD over the past week. The POEM contains 7 symptom based questions with responses rating number of days each symptom is experienced over the past week, from 0 (no days) to 4 (every day), with a maximum score of 28. Higher score means worse outcome.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=69 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=123 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years
Day 15
|
-2.5 Units on a Scale
Standard Deviation 5.17
|
-6.7 Units on a Scale
Standard Deviation 6.09
|
|
Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years
Day 29
|
-3.8 Units on a Scale
Standard Deviation 5.33
|
-7.7 Units on a Scale
Standard Deviation 5.41
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The PGIS (for participants 12 years and older) is a single item patient-rated measure of the participant's AD condition severity at a given point in time. This single item instrument uses a 7-point rating scale, which range from 1 to 7, where 1=Not present to 7=Extremely severe.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=62 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=137 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score
Week 1
|
-0.24 Units on a Scale
Standard Deviation 0.511
|
-0.43 Units on a Scale
Standard Deviation 0.649
|
|
Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score
Week 2
|
-0.26 Units on a Scale
Standard Deviation 0.692
|
-0.60 Units on a Scale
Standard Deviation 0.836
|
|
Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score
Week 3
|
-0.38 Units on a Scale
Standard Deviation 0.871
|
-0.66 Units on a Scale
Standard Deviation 0.913
|
|
Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score
Week 4
|
-0.44 Units on a Scale
Standard Deviation 0.965
|
-0.71 Units on a Scale
Standard Deviation 1.028
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The PGIC (for participants 12 years and older) was used to determine global improvement as assessed by the participant or caregiver. It was used as an anchor to define a responder definition for the peak pruritus scales for 'clinically important responder' and as a sensitivity analysis for defining a 'clinical important difference' on the peak pruritus scales. This single item instrument is a 7-point rating scale, anchored by (1) 'very much improved' to (7) 'very much worse'.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=62 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=137 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Patient Global Impression of Change (PGIC) Score
Day 15
|
3.2 Units on a Scale
Standard Deviation 1.10
|
2.6 Units on a Scale
Standard Deviation 1.07
|
|
Patient Global Impression of Change (PGIC) Score
Day 22
|
3.0 Units on a Scale
Standard Deviation 1.19
|
2.6 Units on a Scale
Standard Deviation 1.04
|
|
Patient Global Impression of Change (PGIC) Score
Day 8
|
3.3 Units on a Scale
Standard Deviation 1.05
|
2.6 Units on a Scale
Standard Deviation 1.10
|
|
Patient Global Impression of Change (PGIC) Score
Day 29
|
2.9 Units on a Scale
Standard Deviation 1.21
|
2.5 Units on a Scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥2 and \<12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The OGIS (for participants ≥2 and \<12 years) is a single item observer-rated measure of the participant's AD condition severity at a given point in time. This single item instrument uses a 7-point rating scale, which ranged from 1 to 7, where 1=Not present to 7=Extremely severe.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=69 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=123 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score
Week 1
|
-0.12 Units on a Scale
Standard Deviation 0.593
|
-0.62 Units on a Scale
Standard Deviation 0.667
|
|
Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score
Week 2
|
-0.27 Units on a Scale
Standard Deviation 0.617
|
-0.93 Units on a Scale
Standard Deviation 0.794
|
|
Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score
Week 3
|
-0.41 Units on a Scale
Standard Deviation 0.770
|
-1.03 Units on a Scale
Standard Deviation 0.822
|
|
Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score
Week 4
|
-0.54 Units on a Scale
Standard Deviation 0.854
|
-1.14 Units on a Scale
Standard Deviation 0.893
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥2 and \<12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
The OGIC (for participants ≥2 and \<12 years ) was used to determine global improvement as assessed by the participant or caregiver. It was used as an anchor to define a responder definition for the peak pruritus scales for 'clinically important responder' and as a sensitivity analysis for defining a 'clinical important difference' on the peak pruritus scales. This single item instrument is a 7-point rating scale, anchored by (1) 'very much improved' to (7) 'very much worse'.
Outcome measures
| Measure |
Vehicle Twice a Day (BID)
n=69 Participants
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=123 Participants
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Observer Reported Global Impression of Change (OGIC) Score
Day 8
|
3.0 Units on a Scale
Standard Deviation 1.08
|
2.3 Units on a Scale
Standard Deviation 0.81
|
|
Observer Reported Global Impression of Change (OGIC) Score
Day 22
|
2.9 Units on a Scale
Standard Deviation 1.16
|
2.4 Units on a Scale
Standard Deviation 0.99
|
|
Observer Reported Global Impression of Change (OGIC) Score
Day 29
|
2.8 Units on a Scale
Standard Deviation 1.07
|
2.2 Units on a Scale
Standard Deviation 1.05
|
|
Observer Reported Global Impression of Change (OGIC) Score
Day 15
|
3.0 Units on a Scale
Standard Deviation 1.10
|
2.3 Units on a Scale
Standard Deviation 0.92
|
Adverse Events
Vehicle Twice a Day (BID)
Crisaborole 2% Twice a Day (BID)
Serious adverse events
| Measure |
Vehicle Twice a Day (BID)
n=131 participants at risk
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 participants at risk
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
Investigations
Myocardial necrosis marker increased
|
0.76%
1/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.38%
1/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
Other adverse events
| Measure |
Vehicle Twice a Day (BID)
n=131 participants at risk
Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
Crisaborole 2% Twice a Day (BID)
n=260 participants at risk
Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1.
|
|---|---|---|
|
General disorders
Application site discolouration
|
0.76%
1/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.5%
9/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Application site irritation
|
0.76%
1/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
1.2%
3/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Application site pain
|
3.8%
5/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
13.1%
34/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Application site paraesthesia
|
0.76%
1/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
2.7%
7/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Application site urticaria
|
0.00%
0/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
1.2%
3/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Pyrexia
|
0.76%
1/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
2.3%
6/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
Conjunctivitis
|
1.5%
2/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
1.2%
3/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
Folliculitis
|
4.6%
6/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.1%
8/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
1.2%
3/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
4/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.5%
9/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
Otitis media acute
|
1.5%
2/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.38%
1/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
Pharyngitis
|
1.5%
2/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
1.2%
3/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
1.2%
3/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
4/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.5%
9/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
1.2%
3/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.3%
3/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
1.5%
4/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
11.5%
15/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
7.7%
20/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.76%
1/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
2.3%
6/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
1.5%
2/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
3/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.76%
1/131 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
1.2%
3/260 • Baseline up to Day 60
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
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