Status:
COMPLETED
Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
Lead Sponsor:
Pfizer
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate atopic dermat...
Eligibility Criteria
Inclusion
- \- Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA.
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) or clinically significant physical examination finding at Screening that in the PI's or designee's opinion may interfere with study objectives.
- Has participated in a previous crisaborole clinical study.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT04360187
Start Date
July 27 2020
End Date
September 8 2021
Last Update
June 7 2022
Active Locations (39)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
2
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510091
3
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
4
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260