The first patient has been enrolled in the pivotal Phase 3 clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential treatment for seborrheic dermatitis. Arcutis Biotherapeutics, Inc. is developing the once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor for seborrheic dermatitis and scalp psoriasis.

“The symptoms of seborrheic dermatitis can have a significant, negative influence on quality of life and can cause psychological distress for millions of affected Americans. Despite that, no novel treatments have been developed for this chronic skin condition in decades, and current topical treatments frequently provide inadequate efficacy or pose safety concerns that limit their use,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer of Arcutis. “In our Phase 2 trial, roflumilast foam was demonstrated to be an effective, safe, and well-tolerated treatment for seborrheic dermatitis. We are now pleased to initiate this single Phase 3 pivotal trial, as we believe roflumilast foam, if approved, has the potential to become a much-needed new standard of care for people with seborrheic dermatitis. Unlike most treatments, roflumilast foam is suitable for all body areas, including hair-bearing areas and the face, and does not pose the safety concerns typically seen with topical steroids.”

The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) is a Phase 3, parallel group, double blind, vehicle-controlled study of the safety and efficacy of roflumilast 0.3% foam administered once-daily in approximately 450 subjects ages nine and older with moderate to severe seborrheic dermatitis. The primary endpoint of the study is the proportion of subjects achieving Investigator Global Assessment (IGA) success, defined as an IGA score of “clear” or “almost clear” plus a 2-point improvement at eight weeks. The Company announced in January 2021 that it had conducted a successful End-of-Phase 2 meeting with the FDA and planned to initiate a single pivotal Phase 3 trial in seborrheic dermatitis.