Phase 3 Findings on Roflumilast Foam 0.3% for Scalp and Body Psoriasis, with Jennifer Soung, MD

Arcutis Biotherapeutics, Inc., previously announced the release of positive phase 3 findings on once-daily roflumilast (Zoryve) foam 0.3% from the randomized, double-blinded, vehicle-controlled ARRECTOR trial, involving adults and adolescents aged 12 years and older with psoriasis impacting the scalp and body.1

The ARRECTOR trial, conducted across 49 sites within the US and Canada, had assessed roflumilast foam’s efficacy and safety as a once-daily topical therapeutic for scalp and body psoriasis. To speak about these findings and the potential approval of the topical drug for patients with psoriasis, the HCPLive team spoke with Jennifer Soung, MD, ARRECTOR investigator and director of clinical research at Southern California Dermatology in Santa Ana.

“A lot of times we think of a foam formulation as only for hair-bearing areas, but really the Arcutis team was very intentional in designing this foam not only to address hair-bearing areas like the scalp, but also the body,” Soung explained. “So the formulation is very elegant and unique. It's meant to also be moisturizing without being irritating. A lot of traditional foams can sting or burn because there's a little bit of alcohol in them, and so it was intentionally designed with no irritant, so no propylene glycol and no ethanol.”

Roflumilast foam 0.3% was given a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025, by the US Food and Drug Administration (FDA). If it is approved, the once-daily treatment could become a new option for individuals living with psoriasis affecting a variety of challenging areas of the body.

"So in the ARRECTOR [and Trial 204 studies], there were over 700 patients that were studied, and two-thirds of patients got improvement in their scalp, which is really amazing for a topical as well as being a topical non-steroidal," Soung said. “When you think of before [roflumilast], the topical non-steroidals have not been really effective. We usually use them and reserve them for sensitive skin areas, or like areas where the skin is a little bit thicker, because you're going to get better efficacy, and on the rest of the body, it just doesn't really work…But what's so amazing about [roflumilast foam is that two-thirds of patients had improvement in their scalp and similar improvements, which we saw in the body and trunk.”

Some of the most notable improvements highlighted by Soung include that at the 8-week mark, 66.4% of those treated with the foam attained Scalp-Investigator Global Assessment (S-IGA) success as opposed to only 27.8% for vehicle (P < .0001). By the same point in time, 45.5% of patients treated with the topical reported Body-Investigator Global Assessment (B-IGA) success as opposed to only 20.1% for vehicle (P < .0001).

To find out more information regarding these new data and their implications for patients with psoriasis, view the full interview above.

The quotes used in this interview summary were edited for the purposes of clarity.

Soung has reported nonfinancial support for manuscript preparation from Arcutis during the conduct of this study; personal fees, honoraria, grants, and/or speaking fees from Amgen, Arcutis, Eli Lilly, AbbVie, Pfizer, LEO Pharma, Regeneron, Sanofi, Dermavant, Novartis Bristol Myers Squibb, Johnson & Johnson, UCB KoBio Labs, Coval Biopharma, Boehringer Ingelheim, Novartis Ortho Dermatologics.

References

1. Arcutis Announces Publication of Positive Data from ARRECTOR Trial Evaluating ZORYVE® (roflumilast) Foam 0.3% in Individuals with Psoriasis in Journal of American Medical Association Dermatology. Arcutis Biotherapeutics. May 7, 2025. https://www.globenewswire.com/news-release/2025/05/07/3076357/0/en/Arcutis-Announces-Publication-of-Positive-Data-from-ARRECTOR-Trial-Evaluating-ZORYVE-roflumilast-Foam-0-3-in-Individuals-with-Psoriasis-in-Journal-of-American-Medical-Association-D.html. Accessed May 15, 2025.