Phase 3 trial of roflumilast shows positive results in scalp, body psoriasis

Arcutis has announced positive topline results from the ARRECTOR pivotal phase 3 trial evaluating roflumilast foam 0.3% for the treatment of adults and adolescents with scalp and body psoriasis, according to a company press release.

“We are excited to share these topline results of roflumilast foam, a once-daily non-steroidal treatment option that was designed to overcome limitations of traditional creams and ointments for hair-bearing areas of the body,” Patrick Burnett, MD, PhD, chief medical officer at Arcutis, said in the release. “These pivotal phase 3 results demonstrate the strong efficacy and tolerability of roflumilast foam for the treatment of scalp and body psoriasis.”

Roflumilast foam is a selective PDE4 inhibitor that has been formulated as an emollient, water-based, moisturizing foam that can be used on the scalp and body.

In the trial, roflumilast showed high efficacy and safety ratings with 67.3% of subjects achieving Scalp-IGA success compared with 28.1% of individuals treated with vehicle. Of those treated with roflumilast, 46.5% also achieved Body-IGA success compared with 20.8% of those treated with vehicle.

Roflumilast also demonstrated statistically significant improvement in scalp and overall itch as measured by Scalp Itch Numeric Rating Scale (NRS) and Worst Itch NRS, respectively.

Following the success of this trial, Arcutis has announced plans to submit a new drug application to the FDA for roflumilast foam for the treatment of seborrheic dermatitis in the first quarter of 2023.