A Phase 3 Trial of OPA-15406 Foam in Ch… | Clinical Trial

Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sumire Dermatology Clinic

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPA-15406

Drug

0.3% foam or 1% foam, topical, twice daily, for 8 weeks

Other names: difamilast

Vehicle

Drug

vehicle, topical, twice daily, for 8 weeks

Primary outcomes

Success rate in Investigator's Global Assessment (IGA)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Drug Information Center

CONTACT

+81-3-6361-7314

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 22, 2025
Registry last updated: Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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