Roflumilast Foam and Cream Show Promise in Multiple Skin Diseases

Roflumilast foam significantly improved both scalp and body psoriasis, with improvement as early as two weeks after treatment initiation, data presented at the 2021 AAD VMX show. Additionally, data presented in posters at the AAD VMX show that roflumilast foam is a safe, well-tolerated, and effective treatment in patients with seborrheic dermatitis and roflumilast cream resulted in rapid and robust improvement in the severity of itch, itch-related sleep loss, and quality of life in patients with chronic plaque psoriasis.

Roflumilast cream and foam from Arcutis Biotherapeutics are investigational once-daily, topical formulations of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.

In the scalp and body psoriasis study, 59.1 percent of patients on roflumilast achieved the primary endpoint of Scalp Investigator’s Global Assessment (S-IGA) success (clear/almost clear and ≥2-grade reduction from baseline) at week eight, versus 11.4 percent of patients receiving vehicle (P<0.0001). In all, 34.3 percent of roflumilast foam-treated and 3.4 percent of vehicle-treated patients were rated clear at week eight. Forty percent of patients treated with roflumilast achieved body IGA success at week eight, compared to 6.8 percent of patients receiving vehicle.

Roflumilast foam was well-tolerated in the study. The incidence of treatment-related adverse events (TEAEs), application site adverse events (AEs), and discontinuations due to AEs were low and similar to vehicle.

“Many current treatment options for psoriasis often carry significant limitations, particularly when being used to treat body areas covered with hair, which result in poor outcomes and additional patient burden,” says lead investigator Leon Kircik, MD, Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, Indiana University Medical Center, and Medical Director, Physicians Skin Care, DermResearch, and Skin Sciences, Louisville, KY. “Roflumilast once-daily foam, a novel formulation specifically designed for use on hair-bearing areas of the body like the scalp, but usable on all areas of the body, demonstrated significant benefit on both scalp and non-scalp areas. These positive results are encouraging for patients and clinicians who are desperate for new treatments that can simplify disease management, be used in all areas of the body, and ultimately improve the patient experience.” 
“Psoriasis and seborrheic dermatitis can significantly impact quality of life and are very challenging to treat, particularly long-term,” says Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer, Arcutis. “These new data add to the growing body of evidence supporting the potential of roflumilast, if approved, as an important, new treatment option for people affected by these chronic dermatological conditions.”