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

Otsuka Pharmaceutical Co., Ltd.41 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis (AD)

Interventions

OPA-15406DRUG

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

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 2 Years

Medical Language ↔ Plain English

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

Locations (1)

Sotobo Children's Clinic

Isumi, Japan

Outcomes

Primary Outcomes

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

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.

Time frame: Week 4

Secondary Outcomes

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

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

Time frame: Week4

Data from ClinicalTrials.gov

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