33460 Roflumilast foam 0.3% treatment of seborrheic dermatitis is effective and safe and improves patient quality of life: Results from a phase 2 study

Abstract

Seborrheic dermatitis is a chronic inflammatory skin condition that may cause discomfort, itching, and reduced quality of life. No novel treatments have been developed in decades. A phase 2, 8-week study investigated once-daily roflumilast foam 0.3%, a selective and highly potent phosphodiesterase-4 inhibitor, in patients with seborrheic dermatitis. Adult patients with seborrheic dermatitis of at least moderate Investigator Global Assessment (IGA) severity affecting ≤20% of body surface area were randomized to roflumilast foam 0.3% (n = 154) or vehicle (n = 72). For the primary endpoint, significantly more roflumilast-treated patients (73.8%) than vehicle-treated patients (40.9%; P < .0001) achieved an IGA score of clear or almost clear plus 2-grade improvement from baseline at week 8; significant differences occurred as early as the first postbaseline visit (week 2, P = .0033). Patients in the roflumilast foam 0.3% group had greater improvement in health-related quality of life (Scalpdex) scores compared with those in the vehicle group at all postbaseline assessments (P ≤ .0019). At Weeks 4 and 8, roflumilast-treated patients had greater improvement in Dermatology Life Quality Index compared with vehicle-treated patients (P ≤ .0380). Roflumilast also increased the percentage of patients achieving a 4-point response on the worst itch-numeric rating scale at all postbaseline visits (evaluated in patients with baseline score ≥4; P ≤ .0009). Rates of application site pain, treatment-related adverse events, and discontinuations due to adverse events were low and comparable to vehicle. These data indicate investigational once-daily roflumilast foam 0.3% is a promising, novel and effective topical therapy that may rapidly improve quality of life in patients with seborrheic dermatitis.