Arcutis Announces Positive Topline Results for INTEGUMENT-INFANT Phase 2 Trial of ZORYVE® (roflumilast) Cream 0.05% in Infants with Mild to Moderate Atopic Dermatitis

Core Insights - Arcutis Biotherapeutics announced positive topline results from the INTEGUMENT-INFANT Phase 2 study for ZORYVE® (roflumilast) cream 0.05% in infants with atopic dermatitis, showing a well-tolerated safety profile and significant efficacy [1][2][4] Study Results - The INTEGUMENT-INFANT study involved 101 infants aged 3 months to less than 24 months, demonstrating that 58% of participants achieved a 75% improvement in the Eczema Area and Severity Index (EASI-75) at Week 4 [6] - Adverse events were low in incidence, primarily mild to moderate, with diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting being the most common [2][4] Product Information - ZORYVE cream is a topical phosphodiesterase 4 (PDE4) inhibitor, indicated for the treatment of mild to moderate atopic dermatitis in pediatric patients aged 2 to 5 years [8][11] - The company plans to submit a supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% for infants in Q2 2026 [6] Industry Context - Atopic dermatitis affects approximately 9.6 million children in the U.S., with symptoms often developing within the first year of life [5][6] - The disease can significantly impact the quality of life for both children and their families, leading to sleep disruption and emotional strain [7]