Core Insights - Arcutis Biotherapeutics announced positive results from the INTEGUMENT-INFANT Phase 2 trial for ZORYVE® (roflumilast) cream 0.05%, showing its effectiveness in treating atopic dermatitis in infants aged 3 months to less than 24 months [1][5][6] Group 1: Clinical Trial Results - ZORYVE cream 0.05% significantly reduced signs and symptoms of atopic dermatitis in infants, with caregivers reporting rapid relief of itch in as little as 10 minutes [2][5] - In the trial, 34.4% of participants achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success at Week 4, and 49% achieved a vIGA-AD score of Clear or Almost Clear [3][4] - The study demonstrated a high safety profile, with only one participant discontinuing due to an adverse event and no serious adverse events reported [2][6] Group 2: Safety and Tolerability - The most frequently reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting, with a high local tolerability rate of ≥97.9% experiencing no application site irritation [2][6] - The safety findings were consistent with previous pediatric studies, reinforcing the well-tolerated nature of ZORYVE cream [5][6] Group 3: Future Developments - Arcutis plans to submit a supplemental New Drug Application for ZORYVE cream 0.05% for infants in Q2 2026, expanding its evidence base for this vulnerable population [6] - Additional studies supporting the ZORYVE portfolio were presented, indicating ongoing commitment to developing effective treatments for various dermatological conditions [7][8]

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