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Not yet recruiting NCT07184645

A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis

Phase III Interventional Atopic Dermatitis (AD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OPA-15406, Vehicle.
Who it may be relevant to
Registry conditions: Atopic Dermatitis (AD). Basic parameters: 3 months — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)

Interventions

  • Drug OPA-15406
    0.3% foam or 1% foam, topical, twice daily, for 8 weeks
  • Drug Vehicle
    vehicle, topical, twice daily, for 8 weeks

Primary outcome measures

  • Success rate in Investigator's Global Assessment (IGA) [Time frame: Week 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Japan · 1 center
  • Sumire Dermatology Clinic — Tokyo

Identifiers

NCT: NCT07184645 · 271-102-00044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗