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

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.

• Authors: Andrew Blauvelt, Zoe D Draelos, Linda Stein Gold, Javier Alonso-Llamazares, Neal Bhatia, Janet DuBois, Seth B Forman, Melinda Gooderham, Lawrence Green, Scott T Guenthner, Adelaide A Hebert, Edward Lain, Angela Y Moore, Kim A Papp, Matthew Zirwas, Saori Kato, Scott Snyder, David Krupa, Patrick Burnett, David R Berk, David H Chu
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 90 Issue 5 Pg. 986-993 (May 2024) ISSN: 1097-6787 [Electronic] United States
• PMID: 38253129 (Publication Type: Randomized Controlled Trial, Clinical Trial, Phase III, Journal Article)
• Copyright: Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Roflumilast
• Aminopyridines
• Immunoglobulin A
• Benzamides
• Cyclopropanes

Topics

• Adult
• Humans
• Adolescent
• Dermatitis, Seborrheic
• Treatment Outcome
• Aminopyridines (adverse effects)
• Immunoglobulin A
• Double-Blind Method
• Severity of Illness Index
• Benzamides
• Cyclopropanes