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A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients with Atopic Dermatitis

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Atopic Dermatitis
Date of first enrollment	29/10/2025
Target sample size	156
Countries of recruitment
Study type	Interventional
Intervention(s)	1% foam or vehicle, topical, twice daily

Outcome(s)

Primary Outcome	IGA success rate at Week 4
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 15age old
Age maximum	<= 70age old
Gender	Both
Include criteria	1) Participants who have been diagnosed AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association) 2) Participants with a history of AD for at least 3 years 3) 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 4) Participants with an IGA score of 2 or 3 at the screening and baseline examinations
Exclude criteria	1) Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination 2) Participants who have been treated with OPA-15406 ointment in the past