Status:
COMPLETED
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
Lead Sponsor:
Pfizer
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
3-23 years
Phase:
PHASE4
Brief Summary
This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mi...
Detailed Description
Approximately 125 subjects will be enrolled. Subjects must have mild-to-moderate AD involving at least 5% treatable %BSA assessed on Baseline/Day 1. Treatable %BSA will be defined as the percent of a ...
Eligibility Criteria
Inclusion
- Aged ≥ 3 months at the screening visit to \< 24 months on baseline/Day 1, diagnosed with AD
Exclusion
- Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2019
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT03356977
Start Date
January 16 2018
End Date
April 12 2019
Last Update
October 10 2019
Active Locations (32)
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1
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
2
Rady Children's Hospital - San Diego/University of California, San Diego
San Diego, California, United States, 92123
3
Rady Children's Hospital
San Diego, California, United States, 92123
4
University of California, San Francisco
San Francisco, California, United States, 94115