Core 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]

Core Insights - Arcutis Biotherapeutics announced positive results from a pivotal Phase 3 study of ZORYVE (roflumilast) foam 0.3% for treating psoriasis of the scalp and body, published in JAMA Dermatology [1][9] Efficacy Results - ZORYVE foam demonstrated significant improvements in co-primary efficacy endpoints, with 66.4% achieving Scalp-Investigator Global Assessment (S-IGA) Success and 45.5% achieving Body-Investigator Global Assessment (B-IGA) Success at Week 8, compared to 27.8% and 20.1% for the vehicle, respectively (P<0.0001) [4][5] - Clinically meaningful improvements in scalp itch were observed, with 65.3% of ZORYVE-treated individuals achieving a significant reduction in itch compared to 30.3% for the vehicle at Week 8 (P<0.0001) [6][8] - At Week 8, 70.9% of ZORYVE-treated individuals achieved at least 75% improvement in Psoriasis Scalp Severity Index (PSSI-75) compared to 31.3% for the vehicle (P<0.001) [13] Study Design - The ARRECTOR study was a Phase 3, randomized, double-blinded, vehicle-controlled trial involving 432 participants aged 12 years and older across 49 sites in the U.S. and Canada [3][5] Safety and Tolerability - ZORYVE foam was well-tolerated, with low incidence of Treatment Emergent Adverse Events (TEAEs) similar to the vehicle group; common adverse events included headache, diarrhea, and nausea [8][9] - Investigator-rated application-site tolerability showed no evidence of irritation for at least 99.2% of patients at all time points [8] Regulatory Status - A Supplemental New Drug Application (sNDA) for ZORYVE foam 0.3% is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) action date set for May 22, 2025 [5][11] Market Context - Psoriasis affects approximately nine million people in the U.S., with more than half experiencing scalp involvement, highlighting the need for effective treatment options [10][11]