A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Trial to Assess the Safety and Efficacy of 0.3% and 1% OPA-15406 Ointments When Administered for 4 Weeks in Pediatric Patients With Atopic Dermatitis
Phase 2
- Conditions
- Atopic Dermatitis
- Registration Number
- JPRN-jRCT2080223429
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka
Exclusion Criteria
- Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
- Subjects who have an active viral skin infection.
- Subjects with a current or history of malignancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number and percentage of subjects experiencing AEs
- Secondary Outcome Measures
Name Time Method IGA, EASI and plasma concentration of OPA-15406