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

Atopic Dermatitis (AD) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372653
• Other study ID #: 271-102-00016
• Status: Completed
• Phase: Phase 3
• Start date: May 23, 2022
• Est. completion date: November 29, 2023

Study information

• Verified date: February 2024
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 29, 2023
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis (AD)
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• OPA-15406
0.3% or 1% ointment, topical, twice daily, for 52 weeks

Locations

Country	Name	City	State
Japan	Sotobo Children's Clinic	Isumi

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate in Investigator's Global Assessment (IGA)	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 subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.	Week 4