Status:
TERMINATED
A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis
Lead Sponsor:
Pfizer
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
7+ years
Phase:
PHASE3
Brief Summary
This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate Atopic Dermatitis...
Eligibility Criteria
Inclusion
- Male or female participants;
- Who were patients with mild to moderate AD aged 2 years old or older and met eligibility criteria for study C3291032 at the time when entering Study C3291032, and completed treatment period in Study C3291032 without safety issues. Or
- Who were patients with mild to moderate AD aged 1 months to \<24 months and met eligibility criteria for Study C3291031 at the time when entering Study C3291031, and completed treatment period in Study C3291031 without safety issues
Exclusion
- Has other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04498403
Start Date
September 14 2020
End Date
December 18 2020
Last Update
August 12 2021
Active Locations (11)
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1
Shirao Clinic of Pediatrics and Pediatric Allergy
Hiroshima, Hiroshima, Japan, 734-0023
2
Chitose dermatology and plastic surgery clinic
Chitose Shi, Hokkaido, Japan, 066-0021
3
Takagi Dermatological Clinic
Obihiro, Hokkaido, Japan, 080-0013
4
Yoshimura Child Clinic
Akashi, Hyōgo, Japan, 674-0068