ARQ-154 (topical roflumilast foam) shows promise in phase 2 study

Positive topline data from a Phase 2 clinical trial suggest ARQ-154 (topical roflumilast foam) from Arcutis Biotherapeutics, Inc. is a potential treatment for seborrheic dermatitis.

Study results show that roflumilast foam 0.3% administered once daily for eight weeks demonstrated statistically significant improvement compared to a matching vehicle foam on key efficacy endpoints in subjects with moderate-to-severe seborrheic dermatitis. On the study’s primary endpoint assessed at week 8, roflumilast foam 0.3% achieved an Investigator Global Assessment (IGA) success rate of 73.8 percent compared to a vehicle rate of 40.9 percent (p<0.0001). IGA success is defined as the achievement of an IGA score of 'clear' or 'almost clear' on a 5-grade scale PLUS at least a two-point change from baseline. 

The onset of effect was rapid, with ARQ-154 statistically separating from vehicle as early as week 2, the first visit after baseline, on IGA success as well as multiple secondary endpoints. For example, at week 8, 64.6 percent  of subjects treated with roflumilast foam who had a baseline Worst Itch Numeric Rating Scale (WI-NRS) score of 4 achieved an itch reduction of at least 4 points compared to 34 percent of vehicle treated subjects. 

Roflumilast foam was well-tolerated, with rates of application site adverse events, treatment-related adverse events, and discontinuations due to adverse events low and similar to vehicle. Only two out of 154 subjects treated with roflumilast foam discontinued the study due to an adverse event, compared to 1 out of 72 subjects treated with the vehicle.

“Seborrheic dermatitis is one of the most common skin conditions dermatologists deal with in adults, right up there with acne, rosacea, psoriasis and eczema. It has an enormous effect on patient’s lives because it is so visible and often embarassing, with red, greasy, flaky areas on the face and scalp that are almost impossible to hide. Making it even worse, many of the more than 10 million sufferers in the US may not know what it is, thereby contributing to the problem of under-treatment and inadequate treatment of the disease,” says Matthew Zirwas, M.D., founder of the Bexley Dermatology Research Clinic and an investigator in the trial. “Current topical treatments for seborrheic dermatitis have major limitations, either having low efficacy, such as with topical antifungals, topical immunomodulators, low potency steroids and prescription shampoos, or high efficacy but unacceptable side effect profiles, such as with high potency topical steroids. Of the major dermatologic diseases, it has the greatest need for new treatment options. I believe these data demonstrate that once daily roflumilast foam is well-tolerated and effective. In my opinion, if approved, it has the potential to become the new standard of care in seborrheic dermatitis.”