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)
Journal of the American Academy of Dermatology（2024）
Therapeutics Clinical Research | Park South Medical | DermResearch | University of Pittsburgh | Henry Ford Medical Center | Brunswick Dermatology Center | Dermatologists of the Central States | Arcutis Biotherapeutics
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.
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