Status:
COMPLETED
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Atopic Dermatitis (AD)
Eligibility:
All Genders
3-2 years
Phase:
PHASE3
Brief Summary
To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis
Eligibility Criteria
Inclusion
- Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association
- Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations
- Subjects who have an IGA score of 2 or 3 at the screening and baseline examinations
Exclusion
- Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05372653
Start Date
May 23 2022
End Date
November 29 2023
Last Update
March 30 2025
Active Locations (1)
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1
Sotobo Children's Clinic
Isumi, Japan