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

Phase 3

Completed

• Conditions: Atopic Dermatitis (AD)
• Interventions: Drug: OPA-15406

• Registration Number: NCT05372653
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-13
• Study Start: 2022-05-23
• Primary Completion: 2022-12-29
• Study Completion: 2023-11-29
• Status Verified: 2024-02
• Results First Submitted: 2024-11-26
• Results First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Results First Posted: 2025-03-30
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OPA-15406	OPA-15406	-

Primary Outcome Measures

Name	Time	Method
Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades)	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 Outcome Measures

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

Trial Locations

Locations (1)

Sotobo Children's Clinic; 🇯🇵 Isumi, Japan