NCT05650320CompletedPhase 3
To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Clinical Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment Versus Vehicle in Pediatric Subjects with Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 25 Mar 2025
Brief summary (registry, in English)
A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (actual)
- First submitted
- 6 Dec 2022
- Start date
- 17 Feb 2023
- Primary completion date
- 21 Jul 2024
- Lead sponsor
- Otsuka Beijing Research Institute
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05650320
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 240
- From 17 Feb 2023 to the primary completion date, 21 Jul 2024
- 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
- 1\. Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
Who the study is looking for
- Sex: Either male or female. Age: 2 to 14 years, inclusive (at time of obtaining informed consent) (only for 4 weeks double blind treatment).
- Diagnosis of AD based on the criteria of Hanifin and Rajka (see Appendix 1).
- Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit(only for 4 weeks double blind treatment).
Age in the registry: 2 years 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 |
|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.