Arcutis Biotherapeutics(US:ARQT) Globenewswire·2025-11-04 13:00Core Insights - Arcutis Biotherapeutics announced the publication of Phase 2 long-term safety data for ZORYVE foam, indicating it is safe, well-tolerated, and effective for treating seborrheic dermatitis for up to 52 weeks [1][8] - ZORYVE foam was approved by the FDA in December 2023 for seborrheic dermatitis and in 2025 for scalp and body plaque psoriasis [1][8] Study Details - The Phase 2 open-label safety trial involved 400 participants aged 12 years and older with moderate to severe seborrheic dermatitis, applying ZORYVE foam once daily [2][3] - The primary endpoint was safety, with 32.5% of participants reporting treatment-emergent adverse events (TEAEs), the most common being COVID-19 (3.8%) and headache (3.3%) [3][4] Efficacy Results - Durable efficacy was observed, with 52.2% of participants achieving an Investigator Global Assessment (IGA) of Clear (0) at Week 52 [5] - At Week 4, 56.4% achieved IGA of Clear or Almost Clear (0 or 1), increasing to 80.4% by Week 52 [5] - Significant improvement in itch was noted, with 71.3% of participants with baseline Worst Itch Numeric Rating Scale (WI-NRS) ≥4 achieving a clinically significant response at Week 24 [6] Mechanism and Recognition - ZORYVE foam is the first topical treatment for seborrheic dermatitis approved in 20 years, utilizing a new mechanism of action targeting phosphodiesterase type 4 (PDE4) [7][9] - ZORYVE has received multiple accolades, including the "2025 Best of Beauty Breakthrough Award" from Allure [10]