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Understanding Roflumilast Foam's FDA Approval for Scalp and Body Psoriasis, with Jennifer Soung, MD
Discover innovative treatments for plaque psoriasis that cater to diverse skin tones, offering effective relief without the risk of discoloration.
The US Food and Drug Administration (FDA) has approved roflumilast (Zoryve) foam 0.3% as a once-daily topical treatment for scalp and body psoriasis in adults and adolescents aged 12 years and older, according to a May 22, 2025, announcement from Arcutis Biotherapeutics. The non-steroidal foam formulation could help address a key unmet need for patients with scalp and body psoriasis. 1
“Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging. A safe, effective foam offers a much-needed solution,” said Jennifer Soung, MD, director of clinical research at Southern California Dermatology and investigator in the ARRECTOR trial, in Arcutis Biotherapeutics' press release.1
Roflumilast is a topical PDE4 inhibitor already approved in cream form for multiple dermatologic conditions. This approval marks the fifth FDA-approved indication for roflumilast overall and the second for the 0.3% foam formulation. The approval is supported by results from a pair of randomized, double-blind, vehicle-controlled trials in the phase 2 Trial 204 and phase 3 ARRECTOR studies, which enrolled a combined 736 patients aged 12 and older with mild to severe plaque psoriasis.2
In ARRECTOR, 66.4% of patients treated with roflumilast foam achieved Scalp-Investigator Global Assessment (S-IGA) Success compared to 27.8% in the vehicle group (P < .0001). For Body-IGA, 45.5% of patients achieved success vs. 20.1% with vehicle (P < .0001). Trial 204 produced similar results, with S-IGA and B-IGA success rates of 56.7% and 39.0%, respectively (vs. 11.0% and 7.4% with vehicle; P < .0001 for both).2
Significant itch relief was seen as early as 24 hours after the first application. At week 8, 63.1% of treated patients had a ≥4-point improvement in Worst Itch-Numeric Rating Scale scores, compared to 30.1% with vehicle (P < .0001). Adverse events were mostly mild to moderate. The most common included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).2
For more on roflumilast foam 0.3% and how this might influence treatment of patients with scalp and body psoriasis, check out our interview with Soung.
Relevant disclosures for Suong include 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, and Ortho Dermatologics.
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