NCT07184645Not yet recruitingPhase 3
A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis
A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% OPA-15406 Foam to the Vehicle in Children With Atopic Dermatitis in Combination With an Open-label, Uncontrolled Trial to Evaluate the Safety and Efficacy of 0.3% and 1% OPA-15406 Foam in Infants Under 2 Years of Age and Children With Atopic Dermatitis (Phase 3 Trial)
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- Sept 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07184645
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 198
- From Sept 2025 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 3 months to 14 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sumire Dermatology Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.