A randomized, double-blind, vehiclecontrolled Phase 2a study evaluating once daily roflumilast foam 0.3% in patients with moderate to severe seborrheic dermatitis

Document Type

Conference Proceeding

Publication Date

5-27-2022

Publication Title

J Clin Aesthet Dermatol

Abstract

Background: Seborrheic dermatitis (SD) is a chronic, inflammatory condition with scaling, erythematous, hyperpigmented, or hypopigmented patches on the scalp, face, upper trunk, and intertriginous areas. Affected individuals may experience itching, stress, or low self-esteem and need effective, well-tolerated treatments that are safe for chronic use on scalp and non-scalp locations. Topical roflumilast is a selective, highly potent phosphodiesterase-4 inhibitor. Here, we report results from a Phase 2, eight-week, vehicle-controlled, double-blind study evaluating safety and efficacy of once-daily roflumilast foam 0.3% in patients with moderate or severe SD (NCT04091646). Objective: Here, we present results from a post-hoc analysis aiming to identify responders to baricitinib 2mg with a proposed clinical tailoring approach based on baseline body surface area (BSA) affected and early clinical improvement from the Phase 3 monotherapy trial BREEZE-AD5 (NCT03435081). Methods: Participants (>18 years) with SD involving less than or equal to 20 percent body surface area (BSA; scalp and/or rest of body) and moderate or severe disease severity (Investigator Global Assessment [IGA] score 3 - 4 ) were randomized 2:1 to once-daily roflumilast 0.3% or vehicle foam (maximum application area ≤20% BSA) for eight weeks. Results: A total of 226 patients were randomized (roflumilast: n=154; vehicle: n=72). Baseline disease characteristics were comparable between groups. The primary efficacy endpoint, IGA Success (Clear/Almost Clear plus >2-grade improvement) at Week 8, was achieved by 73.8 percent and 40.9 percent of the roflumilast and vehicle foam groups, respectively (P<0.0001); 35.5 percent and 15.2 percent, respectively, were clear (IGA=0). Significant efficacy with roflumilast foam 0.3% was observed for numerous secondary endpoints, including IGA Success at Week 2 (33.8% vs 14.7%; P=0.0033) and Week 4 (56.6% vs 28.4%; P=0.0002); erythema success at Week 8 (44.7% vs 21.2%; P=0.0021); scaling success at Week 8 (56.0% vs 27.3%; P=0.0003); and, among patients with baseline Worst Itch Numeric Rating Scale (WI-NRS) >4 (n=184/226 [81.4%]), WI-NRS success (>4-point improveFsment) at Week 2 (52.8% vs 23.2%; P=0.0007) and Week 8 (64.6% vs 34.0%; P=0.0007). The treatment benefit of roflumilast over vehicle was also supported by change from baseline in BSA at Week 8 (P<0.0001) and improvement in Dermatology Life Quality Index (P=0.0380 at Week 8). Excellent tolerability was observed for roflumilast foam 0.3% with greater than or equal to 98 percent of patients rated as having 'no evidence of irritation' by the investigator. Overall incidence of treatment-emergent adverse events (TEAE) and TEAEs leading to discontinuation were low with similar rates between roflumilast and vehicle; no serious AEs were reported. Conclusion: Once-daily roflumilast foam 0.3% significantly improved disease severity, erythema, scaling, quality of life, and itch with onset of action as early as Week 2 (first post-baseline visit). Roflumilast foam 0.3% was well-tolerated with low rates of AEs, supporting further study of roflumilast foam 0.3% as a promising treatment option for patients with moderate or severe SD.

Volume

15

Issue

4 SUPPL 1

First Page

S10

Last Page

S11

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