Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis

Otsuka Pharmaceutical Co., Ltd.366 enrolled

Overview

To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

366

Conditions

Atopic Dermatitis

Interventions

0.3% OPA-15406 ointmentDRUG

Twice daily

1% OPA-15406 ointmentDRUG

Twice daily

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: At least 2 years (at time of obtaining informed consent) * Diagnosis of AD based on the Japanese Dermatological Association's criteria * Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) 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)

Shirao clinic of pediatrics and pediatric allergy

Hiroshima, Japan

Outcomes

Primary Outcomes

Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)

The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).

Time frame: Treatment period (52 weeks)

Secondary Outcomes

Responder Rate of 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 52. 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.

Time frame: Week 52

Responder Rate of Eczema Area and Severity Index 75 (EASI 75)

The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD. The investigator or sub investigator scored the severity (0-3 points) and affected body surface area (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs). EASI 75 is defined as the rate of subjects whose EASI score has improved at least 75% from baseline.

Time frame: Week 52

Data from ClinicalTrials.gov

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