Once-daily roflumilast foam 0.3% for scalp and body psoriasis: A randomized, double-blind, vehicle-controlled phase 2b study.

Abstract

Scalp psoriasis affects most patients with psoriasis but can be difficult to treat. To evaluate efficacy and safety of once-daily roflumilast foam 0.3% on scalp and body psoriasis. In a phase 2b, randomized controlled trial, adults and adolescents ≥12 years old with scalp and body psoriasis were randomized (2:1) to roflumilast foam 0.3% or vehicle for 8 weeks. The primary efficacy endpoint was scalp-Investigator Global Assessment (IGA) Success (score of Clear or Almost Clear plus 2-grade improvement from baseline) at Week 8. Safety and tolerability were also evaluated. Significantly more roflumilast-treated patients (59.1%) than vehicle-treated patients (11.4%) achieved scalp-IGA Success at Week 8 (P < 0.0001); differences favored roflumilast as early as the first postbaseline visit at Week 2 (P = 0.0009). Significant improvements also occurred for secondary endpoints, including body-IGA Success, Scalp Itch-Numeric Rating Scale, and Psoriasis Scalp Severity Index. The safety of roflumilast was generally similar to vehicle. Patients treated with roflumilast experienced low rates of treatment-emergent adverse events (AEs) with few discontinuations due to an AE. Few patients from skin of color backgrounds (11% non-White) and adolescents (0.7%) were included. These results support further development of roflumilast foam for treating scalp and body psoriasis. NCT04128007.