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

Authors

• Andrew Blauvelt, Oregon Medical Research Center, Portland, OR, USA. Electronic address: ablauvelt@oregonmedicalresearch.com.
• Zoe D. Draelos, Dermatology Consulting Services, High Point, NC, USA.
• Linda Stein Gold, Henry Ford Medical Center, Detroit, MI, USA.
• Javier Alonso-Llamazares, Driven Research LLC, Coral Gables, FL, USA.
• Neal Bhatia, Therapeutics Clinical Research, San Diego, CA, USA.
• Janet DuBois, DermResearch, Inc., Austin, TX, USA.
• Seth B. Forman, ForCare Medical Center, Tampa, FL, USA.
• Melinda Gooderham, SKiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough, ON, Canada.
• Lawrence Green, George Washington University School of Medicine, Rockville, MD, USA.
• Scott T. Guenthner, The Dermatology Center of Indiana, PC, and The Indiana Clinical Trials Center, PC, Plainfield, IN, USA.
• Adelaide A. Hebert, UT Health McGovern Medical School, Houston, TX, USA.
• Edward Lain, Sanova Dermatology, Austin, TX, USA.
• Angela Y. Moore, Arlington Research Center, Arlington, TX, USA, and Baylor University Medical Center, Dallas, TX, USA.
• Kim A. Papp, Probity Medical Research and Alliance Clinical Trials, Waterloo, ON, Canada, and University of Toronto, Toronto, ON, Canada.
• Matthew Zirwas, Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley, OH, USA.
• Saori Kato, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
• Scott Snyder, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
• David Krupa, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
• Patrick Burnett, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
• David R. Berk, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
• David H. Chu, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.

Document Type

Journal Article

Publication Date

1-20-2024

Journal

Journal of the American Academy of Dermatology

DOI

10.1016/j.jaad.2023.12.065

Keywords

STRATUM; phase 3; phosphodiesterase 4 inhibitor; randomized controlled trial; roflumilast foam 0.3%; seborrheic dermatitis

Abstract

BACKGROUND: The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions. OBJECTIVE: Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD). METHODS: 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. RESULTS: 79.5% of roflumilast-treated and 58.0% of vehicle-treated patients met the primary endpoint (P < .001); statistically significant differences in IGA Success also favored roflumilast at week 2 (roflumilast: 43.0%; vehicle: 25.7%; P < .001) and week 4 (roflumilast: 73.1%; vehicle: 47.1%; P < .001). Roflumilast was well-tolerated with a low rate of treatment-emergent adverse events. LIMITATIONS: Study limitations include the 8-week treatment period for this chronic condition. CONCLUSIONS: Once-daily roflumilast foam was superior to vehicle in leading to IGA of Clear or Almost Clear plus ≥2-point improvement from baseline at 8 weeks in patients with SD. Longer trials are needed to determine durability and safety of roflumilast foam in SD.

APA Citation

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.; and Chu, David H., "Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial" (2024). GW Authored Works. Paper 4146.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/4146

Department

Dermatology