ZORYVE cream 0.05% provides rapid and effective relief of mild to moderate atopic dermatitis in children ages 2 to 5 and is safe and well toleratedOnce-daily, steroid-free cream can be used anywhere on the body for any durationAbout 1.8 million children ages 2 to 5 with atopic dermatitis are topically treated in the U.S.Sixth FDA approval for ZORYVE in just over three yearsCommercial product expected to be available by the end of October 2025 WESTLAKE VILLAGE, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Arcut ...

Core Insights - Arcutis Biotherapeutics, Inc. is presenting five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, showcasing new data on the long-term safety and efficacy of ZORYVE cream in treating atopic dermatitis (AD) in children aged 2 to 5 [1][2] Group 1: Study Findings - The INTEGUMENT-OLE study demonstrated that ZORYVE cream 0.05% has long-term safety and durable efficacy in children aged 2 to 5 with AD, with a median duration of disease control of 238 days for those switching to a proactive twice-weekly application [2][5] - In the study, 32.7% of participants aged 6 years and older and 28.8% of participants aged 2 to 5 achieved a validated Investigator Global Assessment (vIGA-AD) score of clear or almost clear by Week 4, improving to 55.7% and 63.1% respectively by Week 52 [3][5] - Significant improvements in itch were observed, with 30.9% of participants aged 6 years and older and 41.2% of participants aged 2 to 5 achieving a clinically meaningful reduction in itch at the conclusion of the parent studies, improving to 55.3% and 60.7% respectively after up to 56 weeks of treatment [3][5] Group 2: Clinical Implications - The data highlight the critical need for effective, long-term, steroid-free treatment options for young children with AD, as chronic use of topical steroids can lead to significant adverse events [4][5] - ZORYVE cream formulations were well tolerated, with treatment-related adverse events reported in 4.7% of participants aged 6 years and older and 2.5% of participants aged 2 to 5 [4][5] - The investigational ZORYVE cream 0.05% is currently under FDA review, with a target action date of October 13, 2025, indicating potential for future market introduction [13]