Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome
Sponsored by Otsuka Pharmaceutical Co., Ltd.
About this trial
Last updated 5 years ago
Study ID
271-102-00007
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
15 to 70 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 6 years ago
What is this trial about?
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.
What are the participation requirements?
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