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NCT Number: NCT07173478

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

To investigate the superiority of 1% OPA-15406 foam to the vehicle in adult patients with atopic dermatitis (AD).

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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

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mita 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 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

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

1% foam, topical, twice daily, for 4 weeks

Other names: difamilast

Vehicle

Drug

vehicle, topical, twice daily, for 4 weeks

Primary outcomes

  1. 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 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis (Phase 3 Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Sep 15, 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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