53894 Roflumilast foam 0.3% once daily in patients with seborrheic dermatitis: Improvement in patient reported outcomes and pruritus from a phase 3 trial (STRATUM)

Document Type

Conference Proceeding

Publication Date

9-1-2024

Publication Title

J Am Acad Dermatol

Keywords

clofarabine, phosphodiesterase IV inhibitor, roflumilast, adult, adverse drug reaction, atopic dermatitis, Children's Dermatology Life Quality Index, conference abstract, controlled study, cream, Dermatology Life Quality Index, double blind procedure, drug therapy, female, foam, human, intertrigo, long term care, major clinical study, male, multicenter study, numeric rating scale, patient-reported outcome, phase 3 clinical trial, pruritus, psoriasis, quality of life, randomized controlled trial, seborrheic dermatitis, side effect

Abstract

Roflumilast is a nonsteroidal, highly potent phosphodiesterase 4 inhibitor developed as once-daily cream and foam formulations being studied in patients for long-term treatment of atopic dermatitis and seborrheic dermatitis (SD). Roflumilast cream 0.3% is approved as a once-daily, nonsteroidal cream for patients with chronic plaque psoriasis, including sensitive areas such as intertriginous, face, and genital areas. Efficacy and safety of once-daily roflumilast foam 0.3% in patients ≥9 years old with at least moderate SD from this phase 3 randomized controlled trial (NCT04973228) were reported previously. Roflumilast foam 0.3% (n=304) demonstrated statistically significant improvements in efficacy compared with vehicle (n=153) with low rates of adverse events, which were similar between treatment groups. Here we report the patient-reported outcomes: Worst Itch Numeric Rating Scale (WI-NRS), Scalpdex, and Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI), and local tolerability. Among patients with baseline WI-NRS score ≥2, more roflumilast-treated than vehicle-treated achieved WI-NRS score 0/1 at Week 8 (70.7% vs. 52.9%; P=0.0085), with improvements in itch compared to vehicle as early as 48 hours after first treatment (mean percent change from baseline [CfB]: -27.87% vs. -13.11%; nominal P=0.0024). Roflumilast-treated patients reported greater improvements in least squares (LS) mean CfB DLQI score (-3.8 vs. -2.7; nominal P<0.001), while those with scalp involvement, had greater improvements in LS mean CfB Scalpdex score (-23.21 vs. -15.42; nominal P<0.001) at Week 8. Local tolerability and safety were favorable. Treatment with once-daily roflumilast foam 0.3% reduced pruritus and improved quality of life with favorable tolerability. Sponsored by Arcutis Biotherapeutics, Inc.

Volume

91

Issue

3

First Page

AB304

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