The first child has been enrolled in a Phase 2 open-label study evaluating the safety and tolerability of investigational roflumilast cream 0.05% (Zoryve, Arcutis) in infants aged 3 months to less than 24 months with atopic dermatitis (AD).
INTEGUMENT-INFANT, a Phase 2, open-label, multicenter study, will enroll approximately 35 infants aged 3 months to less than 2 years with mild-to-moderate AD involving at least 3% body surface area.
The study’s primary objective is to evaluate the safety and tolerability of roflumilast cream 0.05% applied once daily over four weeks in this age group. This study builds on the successful results of the ARQ-151-105 (MUSE) study, which evaluated roflumilast cream 0.05% in infants aged 3 months to 24 months with AD.
Roflumilast cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. Roflumilast cream, 0.15%, is indicated for topical treatment of mild-to-moderate AD in adult and pediatric patients 6 years of age and older.
Investigational roflumilast cream 0.05% for the topical treatment of mild-to-moderate AD in children 2 years to 5 years old is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025.
