Trial Outcomes & Findings for A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis (NCT NCT04498403)
NCT ID: NCT04498403
Last Updated: 2021-08-12
Results Overview
An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
Results posted on
2021-08-12
Participant Flow
Participant milestones
| Measure |
Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years
Participants aged \< 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
|
Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Participants aged \>= 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
10
|
|
Overall Study
Completed Follow up
|
30
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
10
|
Reasons for withdrawal
| Measure |
Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years
Participants aged \< 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
|
Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Participants aged \>= 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
29
|
10
|
Baseline Characteristics
A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years
n=30 Participants
Participants aged \< 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
|
Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
n=10 Participants
Participants aged \>= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.3 Years
STANDARD_DEVIATION 3.99 • n=5 Participants
|
31.8 Years
STANDARD_DEVIATION 7.97 • n=7 Participants
|
15.0 Years
STANDARD_DEVIATION 11.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 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
|
30 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
40 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
|
30 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
40 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 up to 28 days after last dose of study drug (maximum up to 12 weeks)Population: Safety population included all participants who took at least 1 dose of study drug. Participants who entered the first Off-Treatment cycle were included.
An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years
n=30 Participants
Participants aged \< 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
|
Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
n=10 Participants
Participants aged \>= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
11 Participants
|
3 Participants
|
Adverse Events
Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years
n=30 participants at risk
Participants aged \< 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
|
Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
n=10 participants at risk
Participants aged \>= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
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|---|---|---|
|
General disorders
Application site pain
|
3.3%
1/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
0.00%
0/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Infections and infestations
Bronchitis
|
3.3%
1/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
0.00%
0/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
10.0%
1/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Infections and infestations
Molluscum contagiosum
|
3.3%
1/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
0.00%
0/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
3/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
0.00%
0/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Infections and infestations
Otitis media acute
|
3.3%
1/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
0.00%
0/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Infections and infestations
Rhinitis
|
3.3%
1/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
0.00%
0/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
10.0%
1/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
10.0%
1/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.3%
1/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
0.00%
0/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
6.7%
2/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
0.00%
0/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.3%
1/30 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
0.00%
0/10 • Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
|
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