Enrollment is now complete for the Phase 2 proof of concept clinical trial evaluating roflumilast foam for the treatment of seborrheic dermatitis. Arcutis Biotherapeutics is developing roflumilast, a selective phosphodiesterase type 4 inhibitor (PDE4 inhibitor), in a once-daily topical foam formulation to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp.
Arcutis anticipates topline data from this trial early in the fourth quarter of 2020. In addition, the Company has begun enrollment in a long-term safety study of roflumilast foam in patients with seborrheic dermatitis. Roflumilast is FDA-approved for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD).
“Seborrheic dermatitis is a common chronic skin disease that primarily occurs on the scalp, face and chest, and is one of the most neglected diseases in dermatology. There are more than six million sufferers in the US, many not knowing what it is and thinking it’s just dry skin, and more than 1.5 million who will receive a prescription topical treatment for this condition each year,” says Mark Jackson, MD, Clinical Professor of Medicine (Dermatology) at the University of Louisville. “I believe a significant need exists for novel non-steroidal therapies to treat this disease, particularly for patients who don’t adequately respond to existing treatments. The greatest reward as a physician comes from seeing patients with distressing chronic skin conditions improve with effective treatments. There is a significant need to find better treatment options for patients with seborrheic dermatitis and I look forward to seeing the results from this trial.”
The Phase 2 proof of concept trial in moderate to severe seborrheic dermatitis is an eight-week, multi-center, multi-national, double blind, vehicle-controlled study of the safety and efficacy of roflumilast foam 0.3% administered once-daily. The primary endpoint of the trial is achievement of an Investigator Global Assessment Scale (IGA) score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline at week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
The Phase 2 long-term safety study is a multicenter, open-label study of roflumilast foam 0.3% applied once daily in patients with moderate to severe seborrheic dermatitis involving up to 20 percent total Body Surface Area (BSA). Cohort 1 will include patients who rolled over from the Phase 2 proof-of-concept trial while Cohort 2 will include patients naïve to treatment with topical roflumilast foam. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement, or progression.