A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis
Not Applicable
Not yet recruiting
- Conditions
- Atopic Dermatitis (AD)
- Interventions
- Drug: Vehicle
- Registration Number
- NCT07184645
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 198
Inclusion Criteria
- Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)
- Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations
- Participants with an IGA score of 2 or 3 at the screening and baseline examinations
Exclusion Criteria
- Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination
- Participants who have been treated with OPA-15406 ointment in the past
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OPA-15406 foam OPA-15406 - Vehicle Vehicle -
- Primary Outcome Measures
Name Time Method Success rate in Investigator's Global Assessment (IGA) Week 4 The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of participants whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sumire Dermatology Clinic
🇯🇵Tokyo, Japan
Sumire Dermatology Clinic🇯🇵Tokyo, Japan