Efficacy and Safety of Roflumilast Foam 0.3% in Patients With Seborrheic Dermatitis in a Phase 3 Trial

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Andrew Blauvelt
Javier Alonso-Llamazares
Neal Bhatia
Zoe Draelos
Janet DuBois
Seth Forman
Melinda Gooderham
Scott Guenthner
Adelaide Hebert
Edward Lain
Angela Moore
Kim Papp
Linda Stein Gold
Matthew Zirwas
Saori Kato
Scott Snyder
David Krupa
Patrick Burnett
David Berk
David Chu


roflumilast, seborrheic dermatitis, phase 3 trial, tolerability


Introduction: Seborrheic dermatitis (SD) is a common, chronic, inflammatory dermatosis that affects patients of all ages with a global prevalence ≥5%. Treatments usually consist of topical therapies, including antifungals and low potency corticosteroids; however, current treatments have limitations such as side effects with long-term use and/or vehicles that can be difficult to use on both hair-bearing and non-hair-bearing areas. Roflumilast is a selective, nonsteroidal, highly potent phosphodiesterase-4 inhibitor once-daily foam under investigation for the treatment of SD. Efficacy, safety, and local tolerability of roflumilast foam 0.3% in patients with SD were demonstrated in a phase 2a and subsequent open-label trial (NCT04091646 and NCT04445987, respectively). Here, we present efficacy, safety, and local tolerability in a phase 3 trial of roflumilast foam 0.3% in patients with SD (NCT04973228).

Methods: This phase 3 randomized, parallel group, double blind, vehicle-controlled trial was conducted in patients ≥9 years old with at least moderate SD affecting scalp and/or non-scalp areas. Patients were randomized 2:1 to apply once-daily roflumilast foam 0.3% (n=304) or vehicle (n=153) for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) Success (IGA of Clear or Almost Clear plus ≥2-grade improvement from baseline) at Week 8. Secondary efficacy endpoints included IGA score of Clear at Week 8, achievement of ≥4-point improvement from baseline in Worst Itch Numeric Rating Score (WI-NRS) among patients with baseline score ≥4 (WI-NRS Success), Overall Assessment of Erythema score of 0, and Overall Assessment of Scaling score of 0. Safety and local tolerability were also evaluated.

Results: Overall, significantly more roflumilast-treated patients than vehicle-treated patients achieved the primary efficacy endpoint of IGA Success (79.5% vs. 58.0%; P<0.0001) and IGA status of Clear (50.6% vs. 27.7%; P<0.0001) at Week 8. Percentages of patients achieving IGA Success and IGA Clear at Weeks 2 and 4 were also greater with roflumilast. Significantly greater percentages of roflumilast- than vehicle-treated patients achieved secondary endpoints of WI-NRS success at Weeks 2, 4, and 8 (62.8% vs. 40.6%; P<0.0001); Overall Assessment of Erythema score of 0 (57.8% vs. 32.0%; P<0.0001) at Week 8; and Overall Assessment of Scaling score of 0 (58.1% vs. 36.5%; P<0.0001) at Week 8. Local tolerability was favorable, with ≥98.9% of patients having no evidence of irritation at Weeks 4 and 8 on investigator-rated assessments and ≥92.3% of patients reporting a score of 0 (no sensation) or 1 (slight warm, tingling sensation; not really bothersome) after application on patient-rated tolerability. Overall incidence of treatment-emergent adverse events (TEAE), serious adverse events, and TEAEs leading to discontinuation were low, with similar rates between roflumilast and vehicle.

Conclusion: Once-daily roflumilast foam provided improvement across multiple efficacy endpoints vs vehicle while demonstrating favorable safety and tolerability in patients ≥9 years old with SD affecting scalp and/or non-scalp body areas.

Sponsored by Arcutis Biotherapeutics, Inc.


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3. ZirwasM, et al. 30th Congress of the European Academy of Dermatology and Venereology (EADV) Virtual, September 29–October 2, 2021.

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