A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis

Phase 3Not Yet RecruitingNCT07184645

Otsuka Pharmaceutical Co., Ltd.198 enrolled

Overview

To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

198

Conditions

Atopic Dermatitis (AD)

Interventions

OPA-15406DRUG

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

VehicleDRUG

vehicle, topical, twice daily, for 8 weeks

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Sumire Dermatology Clinic

Tokyo, Japan

Outcomes

Primary Outcomes

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 participants whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.

Time frame: Week 4

Central Contacts

Drug Information Center

CONTACT

+81-3-6361-7314

Data from ClinicalTrials.gov

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