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Completed

NCT Number: NCT03911401

Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kato Dermatology Clinic

Sapporo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of AD based on the Japanese Dermatological Association's criteria
  • Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
  • 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

Treatment and study plan

0.3% OPA-15406

Drug

Twice daily

1% OPA-15406

Drug

Twice daily

Placebos

Drug

Twice daily

Primary outcomes

  1. Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity

    Time frame: At Week 4

    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.

Secondary outcomes

  1. Change From Baseline in Eczema Area and Severity Index (EASI) Score

    Time frame: Baseline, Week 4

    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, and a negative change from the baseline means improvement and a positive change means worsening. The investigator or sub investigator scored the severity (0-3 points) and affected BSA (%) 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). Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.

  2. Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score

    Time frame: Baseline, Week 4

    The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects aged 7 to 14 years old evaluated the pruritus intensity according to the following criteria. The subjects recorded the level of pruritus and the time and date of evaluation in a pruritus diary.

    0 : None

    • : Mild
    • : Moderate
    • : Severe For subjects aged 2 to 6 years, this would not be evaluated. Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment to the Vehicle in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2019
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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