Jennifer Soung, MD, reacts to the FDA approval of roflumilast foam 0.3%

On May 22, 2025, the FDA approved roflumilast (Zoryve; Arcutis Biotherapeutics) foam 0.3% to treat plaque psoriasis of the scalp and body in individuals aged 12 and older. Jennifer Soung, MD, director of clinical research at Southern California Dermatology and a clinical trial investigator, joined us to break down the approval and the impact it can have in the psoriasis treatment landscape.

"I'm super excited," said Soung. "Parents have been asking for many years, 'Is there anything else besides the topical steroid?' Prior to the approval of roflumilast, we really haven't had a highly effective nonsteroidal option.”

The foam formulation was approved based on findings from the phase 3 ARRECTOR trial and phase 2 Trial 204. In the ARRECTOR trial, 66.4% of participants using roflumilast foam achieved a Scalp-Investigator Global Assessment (S-IGA) Success compared to 27.8% using vehicle (P < 0.0001), while Body-Investigator Global Assessment (B-IGA success) was achieved in 45.5% compared to 20.1% with vehicle (P < 0.0001).

Soung emphasized the psychosocial burden that visible skin disease places on younger patients, stating, "They’re much more susceptible to the psychosocial impacts of plaque psoriasis because it’s such a visible disease,” she said. “They tend to not want to do sports, or they don’t participate in social activities, so they’re much more withdrawn."

The studies also measured improvement in itch, one of the most bothersome symptoms for patients. In ARRECTOR, 65.3% of patients treated with roflumilast experienced significant itch reduction compared to vehicle, with some scalp itch relief evident within 24 hours of the first dose (P = 0.0164). Roflumilast foam 0.3% was well tolerated, with adverse events such as headache, diarrhea, and nausea occurring in fewer than 4% of patients.

“One thing I love about Arcutis and the way they designed their clinical trials is they did their trials in adults and adolescents concurrently,” Soung noted. “That makes it easier for that pediatric patient and their families.”

Click here for full approval details regarding roflumilast foam 0.3% for scalp and body psoriasis.

Editors’ note: Jennifer Soung, MD has relevant disclosures with AbbVie, Alumis, Aslan, Amgen, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Biopharma, Dermavant, Eli Lilly, Galderma, Incyte, Johnson & Johnson, KoBio Labs, LEO, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, and UCB.

Reference:

Fitch, J. FDA approves roflumilast foam 0.3% for scalp, body psoriasis. Contemporary Pediatrics. May 22, 2025. Accessed May 22, 2025. https://www.contemporarypediatrics.com/view/fda-approves-roflumilast-foam-0-3-for-scalp-body-psoriasis