Comparison Trial of OPA-15406 Ointment in Pediatric Patients with Atopic Dermatitis
Phase 3
Completed
- Conditions
- Atopic Dermatitis
- Registration Number
- JPRN-jRCT2080224628
- Lead Sponsor
- Otsuka Pharmaceutical Co., LTD.
- Brief Summary
OPA-15406 (0.3% and 1%) ointment is an effective treatment for pediatric AD in the studied population. Treatment with OPA-15406 (0.3% and 1%) ointment twice daily for up to 4 weeks was safe and well tolerated in both groups of pediatric subjects with AD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 251
Inclusion Criteria
1 Diagnosis of AD based on the Japanese Dermatological Association's criteria
2 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
3 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
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