Matthew J. Zirwas, MD

Credit: docsdermgroup.com

Once-daily roflumilast foam, 0.3%, is effective and safe in treating erythema, itch, and scaling resulting from seborrheic dermatitis, according to new findings.¹

Roflumilast is a potent and selective phosphodiesterase-4 (PDE4) inhibitor that is commonly used as an oral formulation for the treatment of chronic obstructive pulmonary disease, and recent studies have explored the potential of topical roflumilast for managing various dermatologic conditions.

In vitro studies have found that there is a high potency in roflumilast as compared to other PDE4 inhibitors like crisaborole and apremilast and, as a result, this new study into roflumilast foam for seborrheic dermatitis was authored by Matthew J. Zirwas, MD, from Dermatologists of the Central States in Ohio.^2,3

“We present results of a phase 2a randomized clinical trial of roflumilast foam, 0.3%, for once-daily treatment of seborrheic dermatitis on scalp and nonscalp locations,” Zirwas and colleagues wrote.

Background and Findings

The investigators conducted their research between November of 2019 and August of 2020, with a double-blind, vehicle-controlled clinical trial done at 24 sites located in the US and Canada. Their study included adult patients (aged ≥18 years) with a clinical diagnosis of seborrheic dermatitis for a minimum of 3 months.

Additionally, the study participants were included if they had an Investigator Global Assessment (IGA) score of at least moderate (3 or greater), and affecting 20% or less of the body surface area, including scalp, face, trunk, and/or intertriginous areas.

The research team randomized 226 patients to be given either roflumilast foam or vehicle foam, with the participants having a mean age of 44.9 years and an almost even split of men and women. The interventions involved the application of roflumilast foam, 0.3% (n=154) or vehicle foam (n=72) once-daily for 8 weeks, and data analysis was performed from September through October of 2020.

The primary outcome was IGA success, defined as the achievement of an IGA score of clear or almost clear plus a 2-grade improvement from baseline at week 8. The secondary outcomes included IGA success at weeks 2 and 4, achievement of an erythema score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8.

Other secondary outcomes included achieving a 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 a baseline WI-NRS score of 4 or greater. The investigators also evaluated the safety and tolerability of the interventions.

Overall, among the participants treated with roflumilast foam, 73.8% achieved IGA success at week 8, compared to only 40.9% in the vehicle group, with statistically significantly higher rates of IGA success observed from the first time point assessed (week 2).

Those treated with roflumilast foam also reported a greater improvement in mean reduction on the WI-NRS at week 8 compared to the vehicle group (59.3% compared to 36.6%), with a statistically significant difference. Roflumilast foam was found to be well-tolerated, with a similar rate of adverse events to the vehicle foam.

“These results suggest roflumilast foam, 0.3%, has the potential to help address the unmet need for an effective, cosmetically tolerable, treatment for seborrheic dermatitis,” the investigators wrote.

References

1. ^{Zirwas MJ, Draelos ZD, DuBois J, et al. Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial. JAMA Dermatol. Published online May 03, 2023. doi:10.1001/jamadermatol.2023.0846.}
2. ^{Cohen SR, Gordon SC, Lam AH, Rosmarin D. Recalcitrant seborrheic dermatitis successfully treated with apremilast. J Cutan Med Surg. 2020;24(1):90-91. doi:10.1177/1203475419878162PubMedGoogle ScholarCrossref.}
3. ^{Liu D, Chow P, Strawn S, Rajpara A, Wang T, Aires D. Chronic nasolabial fold seborrheic dermatitis successfully controlled with crisaborole. J Drugs Dermatol. 2018;17(5):577-578.}