ong-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients with Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Registration Number
- JPRN-jRCT2080224660
- Lead Sponsor
- Otsuka Pharmaceutical Co., LTD.
- Brief Summary
Administration of 1% OPA-15406 ointment to adult patients with AD and 0.3% or 1% OPA-15406 ointment to pediatric patients with AD for 52 weeks raised no marked safety issues and was well tolerated by most of these patients. In addition, the efficacy of OPA-15406 ointment was demonstrated, such as its improving effect on the severity of rash based on IGA and EASI scores after administration for 52 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 366
1.Diagnosis of AD based on the Japanese Dermatological Association's criteria
2.Atopic dermatitis affecting more than or equal to 5% of body surface area(BSA, excluding scalp) at the screening and baseline examinations
3.IGA score of more than or equal to 2 at the screening and baseline examinations
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse event
- Secondary Outcome Measures
Name Time Method efficacy<br>IGA