NCT05372653CompletedPhase 3
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
A Phase 3, Multicenter, Open-label, Uncontrolled Trial to Evaluate the Efficacy and Safety of OPA-15406 Ointment in Infants Younger Than 2 Years of Age With Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 9 May 2022
- Start date
- 23 May 2022
- Primary completion date
- 29 Dec 2022
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05372653
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 41
- From 23 May 2022 to the primary completion date, 29 Dec 2022
- 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
- -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
Who the study is looking for
- Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association
- Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations
- Subjects who have an IGA score of 2 or 3 at the screening and baseline examinations
Age in the registry: 3 months to 2 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sotobo Children's Clinic Coordinator of this site? Confirm its status | Isumi | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.