28588 Efficacy and safety of roflumilast foam 0.3% in patients with seborrheic dermatitis in a randomized, double-blind, vehicle-controlled phase 2 study
Zirwas M, Draelos ZD, DuBois J, Kircik L, Moore A, Gold LS, Higham RC, Navale L, Burnett P, and Berk DR. 28588 Efficacy and safety of roflumilast foam 0.3% in patients with seborrheic dermatitis in a randomized, double-blind, vehicle-controlled phase 2 study. J Am Acad Dermatol 2021; 85(3):AB47.
J Am Acad Dermatol
Seborrheic dermatitis is a chronic inflammatory skin condition that may cause physical discomfort and emotional burden for patients including itching, stress, and embarrassment. Topical treatments, such as antifungals, steroids, immunomodulators, and dandruff shampoos are used, but there is a need for efficacious and safe options, especially for long-term use. A phase 2, 8-week study investigated roflumilast foam 0.3%, a potent, phosphodiesterase-4 inhibitor designed for once-daily treatment of lesions on the scalp, face, and body. Patients with at least moderate severity (mean IGA 3.1) and mean BSA 3.2% were randomized to roflumilast foam 0.3% (n = 154) or vehicle foam (n = 72). For the primary endpoint, IGA success at Week 8, 73.8% and 40.9% patients achieved IGA of clear/almost clear in the roflumilast foam and vehicle groups, respectively (P <.0001). Improvement in IGA success was statistically significant starting at first postbaseline visit (Week 2, P =.0033) and continuing through Week 8 (P <.0001). Scaling and erythema were both significantly reduced at Week 8 in patients on roflumilast foam compared with vehicle (P ≤.002). Among patients with baseline Worst Itch Numeric Rating Scale (WI–NRS) score ≥4 (n = 184/226), statistically significant 4-point reduction in WI-NRS was achieved as early as Week 2 with roflumilast foam compared with vehicle (P ≤.0007). Rates of application-site pain, treatment-related adverse events, and discontinuations due to adverse events were low and comparable to vehicle. Once-daily roflumilast foam 0.3% was safe, well tolerated, and effective in treating erythema, scaling, and itch of seborrheic dermatitis, and represents a promising and mechanistically novel treatment with early onset of action.