Arcutis Biotherapeutics(US:ARQT) Globenewswire·2025-11-13 13:00Core Insights - Arcutis Biotherapeutics has completed enrollment for the INTEGUMENT-INFANT Phase 2 clinical study, which assesses the safety and tolerability of ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis [1][2][3] - The study aims to provide an alternative treatment option for pediatric patients, as current FDA-approved options are limited for this age group [2][9] - Topline results from the study are expected to be reported in Q1 2026 [4] Company Overview - Arcutis Biotherapeutics is a commercial-stage biopharmaceutical company focused on immuno-dermatology, with a commitment to developing innovative treatments for immune-mediated dermatological diseases [10] - The company has a growing portfolio of advanced targeted topicals approved for treating major inflammatory skin diseases [10] Product Information - ZORYVE cream is a topical phosphodiesterase-4 (PDE4) inhibitor, designed to reduce inflammation and balance the skin's immune system [7][9] - ZORYVE cream 0.05% is specifically formulated for infants and young children with mild to moderate atopic dermatitis [9] - The cream has received multiple awards, including the "2025 Best of Beauty Breakthrough Award" from Allure, highlighting its clinical impact and industry recognition [8] Atopic Dermatitis Context - Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children in the U.S., with 60% of cases developing symptoms within the first year of life [5][6][9] - The condition can significantly disrupt the quality of life for affected children and their families, leading to discomfort, sleep disruption, and emotional strain [6]