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

Keywords

baricitinib, roflumilast, adult, body surface, clinical trial, conference abstract, controlled study, Dermatology Life Quality Index, double blind procedure, drug efficacy, drug safety, drug therapy, drug tolerability, drug withdrawal, erythema, female, foam, human, incidence, major clinical study, male, monotherapy, numeric rating scale, phase 2 clinical trial, phase 3 clinical trial, post hoc analysis, quality of life, randomized controlled trial, scalp, seborrheic dermatitis

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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