Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis
Authors: Zirwas Matthew J. , Draelos Zoe D. , DuBois Janet , Kircik Leon H. , Moore Angela Y. , Stein Gold Linda , Alonso-Llamazares Javier , Bukhalo Michael , Bruce Suzanne , Eads Kimmie , Green Lawrence J. , Guenthner Scott T. , Ferris Laura K. , Forman Seth B. , Kempers Steven E. , Lain Edward , Lynde Charles W. , Pariser David M. , Toth Darryl P. , Yamauchi Paul S. , Higham Robert C. , Krupa David , Burnett Patrick , Berk David R. 
Published: May 2023

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 &amp;lt; .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 &amp;lt; .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