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Not yet taking people in JapanPhase 3

Tests OPA-15406 foam on the skin of infants and children with atopic dermatitis

Tests OPA-15406 foam on young people with the skin condition atopic dermatitis.

Plain-language title generated from the registry record
Registry title: A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis

Key facts

Where
Tokyo, JapanSee the site
Phase
Phase 3

Where in Japan

  • Sumire Dermatology ClinicTokyo, JapanNo longer taking part

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  2. Are travel costs paid?
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  4. What happens if I want to stop?
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Trial details

Who runs it
Otsuka Pharmaceutical Co., Ltd.
Trial code
NCT07184645
Record updated
22 September 2025
Original description
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)Read full original descriptionShow less

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% OPA-15406 Foam to the Vehicle in Children With Atopic Dermatitis in Combination With an Open-label, Uncontrolled Trial to Evaluate the Safety and Efficacy of 0.3% and 1% OPA-15406 Foam in Infants Under 2 Years of Age and Children With Atopic Dermatitis (Phase 3 Trial)

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

Inclusion: 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: 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.

ClinicalTrials.gov NCT07184645