Status:
COMPLETED
A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis
Lead Sponsor:
Pfizer
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
3+ years
Phase:
PHASE3
Brief Summary
This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.
Detailed Description
Approximately 700 participants will be enrolled in an run-in period to receive crisaborole, BID for up to a maximum of 8 weeks to identify crisaborole responders. A responder is defined as a participa...
Eligibility Criteria
Inclusion
- Male or female
- 3 months of age and older
- Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
- Minimum of 5% BSA affected by atopic dermatitis
- ISGA score of Mild (2) or Moderate (3)
Exclusion
- \- Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome).
Key Trial Info
Start Date :
September 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2022
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT04040192
Start Date
September 12 2019
End Date
January 19 2022
Last Update
March 8 2023
Active Locations (44)
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1
First OC Dermatology
Fountain Valley, California, United States, 92708
2
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
3
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States, 80907
4
Colorado Springs Dermatology Clinic, PC
Colorado Springs, Colorado, United States, 80910