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

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.

Department

Dermatology

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