Status:
NOT_YET_RECRUITING
A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Atopic Dermatitis (AD)
Eligibility:
All Genders
3-14 years
Phase:
PHASE3
Brief Summary
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
Eligibility Criteria
Inclusion
- Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)
- Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations
- Participants with an IGA score of 2 or 3 at the screening and baseline examinations
Exclusion
- Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination
- Participants who have been treated with OPA-15406 ointment in the past
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT07184645
Start Date
September 1 2025
End Date
February 1 2027
Last Update
September 22 2025
Active Locations (1)
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1
Sumire Dermatology Clinic
Tokyo, Japan