Arcutis Biotherapeutics, Inc. announced that the Journal of American Academy of Dermatology (JAAD) published positive results from the pivotal Phase 3 STRATUM trial evaluating ZORYVE (roflumilast) foam, 0.3% as a once-daily steroid-free treatment for seborrheic dermatitis. The article was published online, and found that treatment with ZORYVE foam was superior to vehicle, with 80% of individuals achieving the primary efficacy endpoint of Investigator Global Assessment (IGA) Success and 51% of individuals reaching complete clearance at Week 8. ZORYVE foam was approved by the U.S. Food and Drug Administration (FDA) for treatment of seborrheic dermat inflammation in adult and pediatric patients 9 years of age and older in December 2023 and is the first drug approved for seborrheic Dermatitis with a new mechanism of action in over two decades. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was a parallel group, double-blind, vehicle-controlled study evaluating the safety and efficacy of ZORYVE (roflUMilast) foam, 0".

The trial enrolled 457 adults and adolescents with moderate to severeseborrheic dermatitis affecting up to 20% body surface area (BSA), including the scalp, face, trunk, and/or intertriginous areas. The STRATUM study met its primary endpoint, with 80% of roflumilast foam treated individuals reaching IGA Success rate at Week 8 (79.5% ZORYVE foam vs. 58.0% vehicle; p.