Overview
Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome
Status:
Completed
Completed
Trial end date:
2019-12-28
2019-12-28
Target enrollment:
0
0
Participant gender:
All
All
Summary
To demonstrate the superiority of IMP (1% OPA-15406 ointment or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in adult patients with AD.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Criteria
Inclusion Criteria:- Diagnosis of AD based on the Japanese Dermatological Association's criteria
- History of AD for at least 3 years
- Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of
body surface area (BSA, excluding scalp) at the screening and baseline examinations
- IGA score of 2 or 3 at the screening and baseline examinations
Exclusion Criteria:
- 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