Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial


Matthew J. Zirwas, Dermatologists of the Central States, Bexley, Ohio.
Zoe D. Draelos, Dermatology Consulting Services, High Point, North Carolina.
Janet DuBois, DermResearch, Inc, Austin, Texas.
Leon H. Kircik, Icahn School of Medicine at Mount Sinai, New York, New York.
Angela Y. Moore, Arlington Center for Dermatology, Arlington Research Center, Arlington, Texas.
Linda Stein Gold, Henry Ford Medical Center, Detroit, Michigan.
Javier Alonso-Llamazares, Driven Research LLC, Coral Gables, Florida.
Michael Bukhalo, Arlington Dermatology, Rolling Meadows, Illinois.
Suzanne Bruce, SBA Dermatology, Houston, Texas.
Kimmie Eads, The Indiana Clinical Trials Center, PC, Plainfield.
Lawrence J. Green, George Washington University School of Medicine, Rockville, Maryland.
Scott T. Guenthner, The Dermatology Center of Indiana, PC, Plainfield.
Laura K. Ferris, University of Pittsburgh, Department of Dermatology, Pittsburgh, Pennsylvania.
Seth B. Forman, ForCare Medical Center, Tampa, Florida.
Steven E. Kempers, Minnesota Clinical Study Center, Fridley.
Edward Lain, Sanova Dermatology, Austin, Texas.
Charles W. Lynde, University of Toronto, Toronto, Ontario, Canada.
David M. Pariser, Eastern Virginia Medical School, Norfolk.
Darryl P. Toth, XLR8 Medical Research, Windsor, Ontario, Canada.
Paul S. Yamauchi, David Geffen School of Medicine at UCLA, Los Angeles, California.
Robert C. Higham, Arcutis Biotherapeutics, Inc, Westlake Village, California.
David Krupa, Arcutis Biotherapeutics, Inc, Westlake Village, California.
Patrick Burnett, Arcutis Biotherapeutics, Inc, Westlake Village, California.
David R. Berk, Arcutis Biotherapeutics, Inc, Westlake Village, California.

Document Type

Journal Article

Publication Date



JAMA dermatology








IMPORTANCE: Current topical treatment options for seborrheic dermatitis are limited by efficacy and/or safety. OBJECTIVE: To assess safety and efficacy of roflumilast foam, 0.3%, in adult patients with seborrheic dermatitis affecting the scalp, face, and/or trunk. DESIGN, SETTING, AND PARTICIPANTS: This multicenter (24 sites in the US and Canada) phase 2a, parallel group, double-blind, vehicle-controlled clinical trial was conducted between November 12, 2019, and August 21, 2020. Participants were adult (aged ≥18 years) patients with a clinical diagnosis of seborrheic dermatitis for a 3-month or longer duration and Investigator Global Assessment (IGA) score of 3 or greater (at least moderate), affecting 20% or less body surface area, including scalp, face, trunk, and/or intertriginous areas. Data analysis was performed from September to October 2020. INTERVENTIONS: Once-daily roflumilast foam, 0.3% (n = 154), or vehicle foam (n = 72) for 8 weeks. MAIN OUTCOMES AND MEASURES: The main outcome was IGA success, defined as achievement of IGA score of clear or almost clear plus 2-grade improvement from baseline, at week 8. Secondary outcomes included IGA success at weeks 2 and 4; achievement of erythema score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; achievement of scaling score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; change in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline; and WI-NRS success, defined as achievement of 4-point or greater WI-NRS score improvement in patients with baseline WI-NRS score of 4 or greater. Safety and tolerability were also assessed. RESULTS: A total of 226 patients (mean [SD] age, 44.9 [16.8] years; 116 men, 110 women) were randomized to roflumilast foam (n = 154) or vehicle foam (n = 72). At week 8, 104 (73.8%) roflumilast-treated patients achieved IGA success compared with 27 (40.9%) in the vehicle group (P < .001). Roflumilast-treated patients had statistically significantly higher rates of IGA success vs vehicle at week 2, the first time point assessed. Mean (SD) reductions (improvements) on the WI-NRS at week 8 were 59.3% (52.5%) vs 36.6% (42.2%) in the roflumilast and vehicle groups, respectively (P < .001). Roflumilast was well tolerated, with the rate of adverse events similar to that of the vehicle foam. CONCLUSIONS AND RELEVANCE: The results from this phase 2a randomized clinical trial of once-daily roflumilast foam, 0.3%, demonstrated favorable efficacy, safety, and local tolerability in the treatment of erythema, scaling, and itch caused by seborrheic dermatitis, supporting further investigation as a nonsteroidal topical treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04091646.