WESTLAKE VILLAGE - Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of American Academy of Dermatology (JAAD) published positive results from the pivotal Phase 3 STRATUM trial evaluating ZORYVE 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 dermatitis 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.

'Despite being very common, seborrheic dermatitis has traditionally been a disease with limited treatment options. It also can have a significant impact on quality of life,' stated Dr. Andrew Blauvelt, MD, MBA, lead study author and investigator at the Oregon Medical Research Center. 'The publication of the Phase 3 STRATUM study results in the Journal of American Academy of Dermatology further validates the significance of roflumilast foam as a new treatment option for seb derm, one that provides treatment success in eight of ten patients, along with significant and rapid improvements in key signs and symptoms of disease, as early as two weeks. These results highlight the effectiveness and safety of roflumilast foam, a steroid-free treatment and the first novel mechanism of action approved for seb derm in two decades. It should end suffering from this long-neglected condition.'

'Seborrheic dermatitis is challenging to manage, and often people with the disease require several different treatments for different areas of their body. Our focus has been to simplify the treatment of seborrheic dermatitis with an effective once-daily steroid-free foam that is suitable for use anywhere on the body for any duration and on all hair and skin types,' said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. 'We are pleased that this manuscript is now available to provide dermatology clinicians with a greater understanding of the clinical data supporting ZORYVE foam as a newly approved treatment option for their patients.'

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, 0.3% in seborrheic dermatitis. The trial enrolled 457 adults and adolescents with moderate to severe seborrheic 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

(C) 2024 Electronic News Publishing, source ENP Newswire