Core 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]

Core Insights - Arcutis Biotherapeutics announced new data on ZORYVE® (roflumilast) cream, showing improvements in quality of life for atopic dermatitis patients, particularly in reducing sleep disruptions and providing long-term disease control for individuals aged 2 years and older [1][2][5] Clinical Data - ZORYVE cream demonstrated significant improvements in sleep and itch reduction in patients aged 2 to 5 years and 6 years and older, based on patient-reported outcomes from three Phase 3 trials [3][6] - The treatment was well-tolerated, with adverse events reported in ≤6% of patients, and serious adverse events in <1% [6][12] Long-term Efficacy - Long-term data from the INTEGUMENT-OLE trial indicated that ZORYVE cream maintained or improved disease control over 56 weeks, with a notable percentage of patients achieving 'Clear' or 'Almost Clear' status [8][12] - The median duration of disease control for patients switching to twice-weekly treatment was 238 days for children aged 2-5 and 281 days for older patients [12] Product Recognition - ZORYVE has received multiple awards, including the "2025 Best of Beauty Breakthrough Award" from Allure and the National Psoriasis Foundation's Seal of Recognition, highlighting its clinical impact and industry recognition [10] Indications and Usage - ZORYVE cream is indicated for the topical treatment of mild to moderate atopic dermatitis in pediatric patients aged 2 to 5 years and in patients aged 6 years and older [11][13]

Core Viewpoint - Arcutis Biotherapeutics has initiated a Phase 2 open-label study for ZORYVE (roflumilast) cream 0.05% in infants with atopic dermatitis, marking a significant step in addressing unmet needs in pediatric dermatology [1][2][3] Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing urgent needs in dermatological diseases [15] Study Details - The INTEGUMENT-INFANT study will enroll approximately 35 infants aged 3 months to less than 2 years with mild to moderate atopic dermatitis, evaluating the safety and tolerability of roflumilast cream applied once daily over four weeks [3][9] - This study builds on previous successful results from the ARQ-151-105 (MUSE) study, which also evaluated roflumilast cream in infants [3] Atopic Dermatitis (AD) Insights - Atopic dermatitis is a chronic condition affecting approximately 9.6 million children in the United States, with up to 60% of cases developing symptoms within the first year of life [5][9] - The condition significantly impacts families by disrupting sleep and increasing the risk of skin infections, highlighting the need for effective treatments [2] ZORYVE Product Information - ZORYVE is the first and only branded topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, representing a next-generation topical PDE4 inhibitor [6][7] - ZORYVE cream 0.15% is currently under FDA review for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years, with a target action date of October 13, 2025 [8]