ARQT - Enrollment underway in Arcutis Bio's late-stage study of roflumilast foam in seborrheic dermatitis
Arcutis Biotherapeutics (ARQT) announces enrollment of the first patient in its single Phase 3 clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential treatment for seborrheic dermatitis.The Phase 3 STRATUM (STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis) will evaluate safety and efficacy of roflumilast 0.3% foam administered once-daily in approx. 450 subjects ages nine and older.The primary endpoint 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.In January 2021, following successful FDA meeting, the company advanced roflumilast foam into Phase 3 study in seborrheic dermatitis.
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Enrollment underway in Arcutis Bio's late-stage study of roflumilast foam in seborrheic dermatitis