FDA Approves Effective Topical Foam for Treating Scalp and Body Plaque Psoriasis

The U.S. Food and Drug Administration (FDA) has granted approval for Zoryve (roflumilast) topical foam 0.3% developed by Arcutis Biotherapeutics, specifically for managing plaque psoriasis affecting the scalp and body. This medication is suitable for adults and adolescents aged 12 years and older. Notably, Zoryve is a steroid-free, once-daily treatment option, offering a convenient approach for patients.

The approval followed positive results from comprehensive clinical trials, including the Phase III ARRECTOR trial and a Phase II trial (Trial 204). In these studies, a total of 736 participants with mild to severe plaque psoriasis on the scalp and body were randomized to apply either Zoryve foam or a placebo foam daily over an eight-week period. The efficacy was assessed using the Investigator Global Assessment (IGA) scale.

Results demonstrated significant improvement, with 66.4% of patients in the ARRECTOR trial achieving success on the Scalp-IGA at week eight, compared to 27.8% treated with placebo. Similarly, 45.5% achieved Body-IGA success versus 20.1% on placebo. The Phase II trial echoed these findings, with 56.7% of patients reaching Scalp-IGA success and 39.0% achieving Body-IGA success.

According to Jennifer Soung, M.D., clinical director at Southern California Dermatology, Zoryve foam not only effectively clears psoriasis plaques but also provides rapid itch relief. Its safety profile supports indefinite use, and its two formulations, cream and foam, offer healthcare providers flexible treatment options.

This approval marks a significant advancement in psoriasis therapy, particularly as it allows for comprehensive management of scalp and body psoriasis with a single prescription, transforming the treatment landscape for patients with this chronic condition.

source: https://medicalxpress.com/news/2025-05-fda-topical-foam-plaque-psoriasis.html