Overview

Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome

Status:
Completed
Trial end date:
2019-12-28
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
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