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Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data of ZORYVE® (roflumilast) Foam 0.3% in Individuals with Seborrheic Dermatitis in American Journal of Clinical Dermatology
ZORYVE foam 0.3% was safe, well-tolerated, and demonstrated durable and continuously improving efficacy in the treatment of seborrheic dermatitis up to 52
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"ZORYVE foam 0.3% was safe, well-tolerated, and demonstrated durable and continuously improving efficacy in the treatment of seborrheic dermatitis up to 52 weeksOnce-daily ZORYVE foam 0.3% is approved to treat seborrheic dermatitis in adults and adolescents 9 years of age and older WESTLAKE VILLAGE, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology, today announced that the American Journal of Clinical Dermatology published data from the Phase 2 long-term safety open-label extension (OLE) study that demonstrated once-daily ZORYVE® (roflumilast) foam 0.3% is safe, well-tolerated, and efficacious for up to 52 weeks of treatment in individuals with seborrheic dermatitis. ZORYVE foam was approved in December 2023 by the U.S. Food & Drug Administration (FDA) for the topical treatment of seborrheic dermatitis in adults and adolescents 9 years of age and older; in 2025 it was also approved for the topical treatment of scalp and body plaque psoriasis in adults and adolescents 12 years of age and older and is available in pharmacies nationwide. “In my practice, I often see individuals with seborrheic dermatitis struggling with persistent itching, redness, and scaling in visible areas like the scalp, face, and chest. For many, this chronic condition is not only uncomfortable but also affects their self-esteem and quality of life,” said Andrew Alexis, MD, MPH, New York-based dermatologist and lead author of the paper. “While topical antifungals, topical corticosteroids, and medicated shampoos are often used, these treatment routines can be complex and often fall short of desired patient outcomes. ZORYVE foam represents a meaningful advancement for individuals living with this burdensome disease.” This Phase 2, open-label safety trial was conducted in individuals aged ≥12 years with moderate to severe seborrheic dermatitis who had previously been treated with ZORYVE foam in a separate Phase 2 double-blind study or were treatment-naive. During the study, all participants (n=400) applied ZORYVE foam once daily, as a monotherapy treatment, to all areas of their bodies impacted by seborrheic dermatitis, including on the scalp, face, trunk, and intertriginous areas. Once patients' disease had cleared (IGA=0) they were able to stop trea...