Phase 3 Trial Supports Roflumilast for Pediatric AD

Phase 3 Trial Supports Roflumilast for Pediatric AD

Lead author on recent research, Lawrence Eichenfield, MD, said if approved, this treatment could fill a “significant gap.”

Arcutis Announces Publication of Positive Data from INTEGUMENT-PED Trial Evaluating ZORYVE® (roflumilast) Cream 0.05% in Children 2 to 5 Years Old with Mild to Moderate Atopic Dermatitis in Pediatric Dermatology - Arcutis Biotherapeutics

ZORYVE® (roflumilast) cream 0.05% improved atopic dermatitis (AD) across all primary and secondary efficacy endpoints, with significant improvement as early as Week 1 on multiple efficacy endpoints.   39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in Eczema Area and Severity Index (EASI-75), a key secondary endpoint. Children treated with ZORYVE cream experienced improvement in itch as early as 24 hours.  Effic…