Efficacy and Safety of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis in a Randomized, Double-blind, Vehicle-controlled Phase 2 Study

Document Type

Conference Proceeding

Publication Date

10-27-2021

Publication Title

J Cutan Med Surg

Abstract

Introduction: Seborrheic dermatitis is a chronic inflammatory skin condition, which may cause physical discomfort and emotional burden for patients including itching, stress, and embarrassment. Topical treatments, such as antifungals, steroids, immunomodulators, and dandruff shampoos are used, but there is a need for efficacious and safe options, especially for long-term use. Methods, Results: A phase 2, 8-week study investigated roflumilast foam 0.3%, a potent, phosphodiesterase-4 inhibitor designed for once-daily treatment of lesions on the scalp, face, and body. Patients with at least moderate severity (mean IGA 3.1) and mean BSA 3.2% were randomized to roflumilast foam 0.3% (n = 154) or vehicle foam (n = 72). For the primary endpoint, IGA success at Week 8, 73.8% and 40.9% patients achieved IGA of clear/almost clear in the roflumilast foam and vehicle groups, respectively (P < 0.0001). Improvement in IGA success was statistically significant starting at first post-baseline visit (Week 2, P = 0.0033) and continuing through Week 8 (P < 0.0001). Scaling and erythema were both significantly reduced at Week 8 in patients on roflumilast foam compared to vehicle (P ≤ 0.002). Among patients with baseline Worst Itch Numeric Rating Scale (WI-NRS) score ≥4 (n = 184/226), statistically significant 4-point reduction in WI-NRS was achieved as early as Week 2 with roflumilast foam compared to vehicle (P ≤ 0.0007). Rates of application-site pain, treatment-related adverse events, and discontinuations due to adverse events were low and comparable to vehicle. Conclusions: Once-daily roflumilast foam 0.3% was safe, well tolerated, and effective in treating erythema, scaling, and itch of seborrheic dermatitis, and represents a promising and mechanistically novel treatment with early onset of action. Learning Objective To gain awareness about a potential new non-steroidal class of topical treatment for patients with seborrheic dermatitis To understand the efficacy, safety, and tolerability of once-daily treatment with roflumilast foam 0.3% for 8 weeks in patients with seborrheic dermatitis To learn about the baseline signs and symptoms of seborrheic dermatitis, specifically the burdensomeness of itch. Takeaway Message Once-daily roflumilast foam 0.3% was well tolerated and provided safe and effective treatment of erythema, scaling, and itch and may be a novel treatment for seborrheic dermatitis.

Volume

25

Issue

1 SUPPL

First Page

62S

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