To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
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
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
Parallel
OPA-15406
Drug0.3% foam or 1% foam, topical, twice daily, for 8 weeks
Vehicle
Drugvehicle, topical, twice daily, for 8 weeks
Success rate in 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 4. Incidence of success in IGA is defined as the rate of participants whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.
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