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Topical roflumilast demonstrates positive topline data from phase 2 trial


Arcutis Biotherapeutics announces topline results from its recent phase 2 clinical study investigating topical roflumilast foam for the treatment of seborrheic dermatitis.

Arcutis Biotherapeutics announces topline results from its phase 2 trial investigating ARQ-154 (topical roflumilast foam, Arcutis Biotherapeutics) as a treatment for seborrheic dermatitis.

“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 embarrassing, with red, greasy, flaky areas on the face and scalp that are almost impossible to hide,” says Matthew Zirwas, M.D., founder of the Bexley Dermatology Research Clinic and an investigator in the trial. “Making it even worse, many of the more than 10 million sufferers in the U.S. may not know what it is, thereby contributing to the problem of under-treatment and inadequate treatment of the disease.”

Roflumilast foam 0.3% is a once-daily topical phosphodiesterase type 4 (PDE4) inhibitor designed to treat inflammatory dermatoses in hair-bearing areas of the body. PDE4 is defined as an intracellular enzyme that increases production of pro-inflammatory mediators while decreasing production of anti-inflammatory mediators and has been linked to a variety of inflammatory diseases including eczema, psoriasis and chronic obstructive pulmonary disease (COPD).

“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,” says Dr. Zirwas. “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.”

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The phase 2, multi-national, double-blind, multicenter, vehicle-controlled, 8-week clinical study enrolled 226 adult patients with moderate-to-severe seborrheic dermatitis to evaluate the safety and efficacy of roflumilast foam 0.3%. The topical was administered once daily to affected areas located on the body, face and scalp.

Results of the study demonstrated 73.8% of roflumilast-treated patients achieved Investigator Global Assessment (IGA) success, defined as clear (0) or almost clear (1) on a 5-grade scale plus a minimum of a two-point change from baseline, versus 40.9% vehicle (p<0.0001).

The topical also showed statical separation from vehicle as early as week 2, the first visit following baseline, on IGA success and other secondary endpoints, according to a press release. At week 8, 64.6% of roflumilast patients with a baseline Worst Itch Numeric Rating Scale (WI-NRS) score of 4 had achieved itch reduction of at least 4 points versus 34% of vehicle (p=0.0007).

The company also reports roflumilast was well-tolerated in the study, with 1.3% of subjects discontinuing roflumilast due to an adverse event versus 1.4% vehicle.

“With once-a-day dosing, roflumilast foam potentially offers the convenience of a single, easy to use product to treat seborrheic dermatitis in all body locations where a patient might be affected,” says Patrick Burnett, M.D., Ph.D., FAAD, and chief medical officer of Arcutis.

“Unlike creams and ointments, roflumilast foam is suitable for use in hair-bearing areas; unlike steroids, it is expected to be suitable for long-term use on the face; and unlike shampoos, it is an elegant, quick drying, leave-in foam that doesn’t need to be rinsed out.”

Roflumilast foam is the first topical for seborrheic dermatitis to offer a novel mechanism of action in decades, notes Dr. Burnett. If the drug performs well in phase 3 trials and received approval, it could significantly affect treatment outcomes and quality of life for patients with the disease, he adds.


1. BioSpace. (2020, September 29). Arcutis Announces Positive Topline Data from Phase 2 Clinical Trial Evaluating ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Seborrheic Dermatitis. Retrieved October 01, 2020, from https://www.biospace.com/article/releases/arcutis-announces-positive-topline-data-from-phase-2-clinical-trial-evaluating-arq-154-topical-roflumilast-foam-as-a-potential-treatment-for-seborrheic-dermatitis-/

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