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

NCT07184645 · tracked via the Priya Life Science Japan tracker

Sponsor

Otsuka Pharmaceutical Co., Ltd

Phase

Phase 3

Started

2025-09

Last updated

2025-09-22

Condition(s) studied

Atopic Dermatitis (AD)

Investigational drug(s) / intervention(s)

OPA-15406 →Vehicle

OPA-15406: 0.3% foam or 1% foam, topical, twice daily, for 8 weeks

Vehicle: vehicle, topical, twice daily, for 8 weeks

Study summary

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

Eligibility

Sex

ALL

Min age

3 Months

Max age

14 Years

Healthy volunteers

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

Primary outcome measure(s)

Success rate in Investigator's Global Assessment (IGA) — Week 4
The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of participants whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.

Trial sites (1)

Facility	City	Region	Status
Sumire Dermatology Clinic	Tokyo	Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07184645 on ClinicalTrials.gov ↗ ← All trials in Japan