Arcutis initiates phase 3 trial of roflumilast foam for seborrheic dermatitis

Arcutis Biotherapeutics has enrolled the first patient in a phase 3 clinical trial of topical roflumilast foam for the treatment of seborrheic dermatitis, according to a press release.

The parallel-group, double-blind, vehicle-controlled STRATUM study will evaluate the safety and efficacy of roflumilast 0.3% foam (ARQ-154) administered once daily in approximately 450 subjects aged 9 years and older with moderate to severe seborrheic dermatitis.

“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,” Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, said in the release. “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.”