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NCT07173478Not yet recruitingPhase 3

A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis (Phase 3 Trial)

Source: ClinicalTrials.gov · Last updated 15 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 1% OPA-15406 foam to the vehicle in adult patients with atopic dermatitis (AD).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
156 (estimated)
First submitted
7 Sept 2025
Start date
Oct 2025
Primary completion date
Dec 2026
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
NCT number
NCT07173478

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 156
  • From Oct 2025 to the primary completion date, Dec 2026
  • 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 AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)
  • Participants with a history of AD for at least 3 years
  • 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: 15 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mita Dermatology Clinic
Coordinator of this site? Confirm its status
TokyoJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.