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Completed

NCT Number: NCT05372653

A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis

To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis

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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

3 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sotobo Children's Clinic

Isumi, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association
  • Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations
  • Subjects who have an IGA score of 2 or 3 at the screening and baseline examinations

Exclusion criteria

-Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination

Treatment and study plan

OPA-15406

Drug

0.3% or 1% ointment, topical, twice daily, for 52 weeks

Other names: difamilast

Primary outcomes

  1. Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades)

    Time frame: Week 4

    The investigator or sub investigator assessed the skin symptoms using IGA (Investigator's Global Assessment). The investigator or sub investigator 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 was defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.

Secondary outcomes

  1. Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI)

    Time frame: Week4

    Response (improvement) in EASI 75 was defined as a decrease by ≥75% in the percent change from baseline in the total score of EASI.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 3, Multicenter, Open-label, Uncontrolled Trial to Evaluate the Efficacy and Safety of OPA-15406 Ointment in Infants Younger Than 2 Years of Age With Atopic Dermatitis

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 13, 2022
Registry last updated
Mar 30, 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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