Comparison Trial of OPA-15406 Ointment in Adult Patiens with Atopic Dermatitis
Phase 3
Completed
- Conditions
- Atopic Dermatitis
- Registration Number
- JPRN-jRCT2080224607
- Lead Sponsor
- Otsuka Pharmaceutical Co., LTD.
- Brief Summary
OPA-15406 1% ointment is an effective treatment for adult AD in the studied population. Treatment with OPA-15406 1% ointment BID for up to 4 weeks was safe in adult subjects with AD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 364
Inclusion Criteria
1.Diagnosis of AD based on the Japanese Dermatological Association's criteria
2. History of AD for at least 3 years
3. 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
4. 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 28days prior to the baseline examination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>IGA
- Secondary Outcome Measures
Name Time Method efficacy<br>EASI, VRS