Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial

• Published in: Journal of the American Academy of Dermatology 2024-05, Vol.90 (5), p.986-993
• Main Authors: Blauvelt, Andrew, Draelos, Zoe D., Stein Gold, Linda, Alonso-Llamazares, Javier, Bhatia, Neal, DuBois, Janet, Forman, Seth B., Gooderham, Melinda, Green, Lawrence, Guenthner, Scott T., Hebert, Adelaide A., Lain, Edward, Moore, Angela Y., Papp, Kim A., Zirwas, Matthew, Kato, Saori, Snyder, Scott, Krupa, David, Burnett, Patrick, Berk, David R., Chu, David H.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aminopyridines - adverse effects; Benzamides; Cyclopropanes; Dermatitis, Seborrheic; Double-Blind Method; Humans; Immunoglobulin A; phase 3; phosphodiesterase 4 inhibitor; randomized controlled trial; roflumilast foam 0.3; seborrheic dermatitis; Severity of Illness Index; STRATUM; Treatment Outcome
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2023.12.065

The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions. Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD). In this phase 3, double-blinded trial, patients with SD were randomly assigned (2:1 ratio) to once-daily roflumilast foam 0.3% or vehicle foam for 8 weeks. The primary efficacy outcome was Investigator Global Assessment (IGA) Success at week 8, defined as IGA of 0 (Clear) or 1 (Almost Clear) plus ≥2-point improvement from baseline. Safety was also assessed. 79.5% of roflumilast-treated and 58.0% of vehicle-treated patients met the primary endpoint (P