A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis

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 Criteria:

• 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 Criteria:

• 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