Zoryve foam delivers a safe, effective and convenient option that doesn’t contain steroids for people who have psoriasis and are age 12 or over.
United States: The U.S. Food and Drug Administration (FDA) has given its approval for Zoryve (0.3% roflumilast foam) to help treat plaque psoriasis for both the scalp and body in people aged 12 and above. The new drug approval now allows this medication to be used once a day without steroids, as reported by HealthDay.
Clinical Trials Demonstrate Significant Effectiveness
Approval was based on results from two major clinical trials — ARRECTOR and Trial 204 — involving 736 patients aged 12 and older with psoriasis on the scalp and body. Participants were randomly assigned to receive either Zoryve foam 0.3% or a vehicle foam over eight weeks. Effectiveness was measured using the Investigator Global Assessment (IGA) scale.
ARRECTOR Trial Results:
Scalp-IGA success (almost clear or clear with ≥2-point improvement) at week 8:
- Zoryve: 66.4%
- Vehicle: 27.8%
Body-IGA success at week 8:
- Zoryve: 45.5%
- Vehicle: 20.1%
Trial 204 Results:
Scalp-IGA success at week 8:
- Zoryve: 56.7%
- Vehicle: 11.0%
Body-IGA success at week 8:
- Zoryve: 39.0%
- Vehicle: 7.4%
Expert Insight: Convenient and Effective Treatment
Dr. Jennifer Soung, director of clinical research at Southern California Dermatology and a clinical trial investigator, shared:
“Zoryve foam not only effectively clears psoriasis plaques on the scalp and body but also provides rapid itch relief. It can be safely used for any duration and comes in two convenient formulations—cream or foam—allowing healthcare providers to tailor treatment. This medication enables patients to manage psoriasis on their whole body with one prescription, transforming the treatment landscape.”