Phase 3 Trial Success: ZORYVE Foam 0.3% for Seborrheic Dermatitis Published in JAAD

A new non-steroidal foam treatment for seborrheic dermatitis has been developed and is showing promising results. ZORYVE® (roflumilast) topical foam, at a concentration of 0.3%, has received approval for daily use in treating the skin condition in individuals aged nine and above. The foam is the first of its kind to be approved with a novel mechanism of action in over twenty years and has been proven effective in a pivotal Phase 3 clinical trial.

The pivotal trial, known as STRATUM, was a double-blind, vehicle-controlled study that involved 457 participants with moderate to severe seborrheic dermatitis. The results, published in the Journal of American Academy of Dermatology, demonstrated that 80% of individuals using ZORYVE foam achieved the primary efficacy endpoint of Investigator Global Assessment (IGA) Success by Week 8, with 51% reaching complete clearance. The foam was found to be superior to the control treatment and showed significant improvements in key symptoms such as itchiness, scaling, and redness.

Dr. Andrew Blauvelt, the lead author of the study, highlighted the impact of seborrheic dermatitis on quality of life and the limited treatment options traditionally available. The publication of the study results validates the significance of roflumilast foam as a new and effective treatment option. It is designed to be used once daily and is suitable for all skin and hair types, offering a convenient and effective solution for managing the condition.

Patrick Burnett, the chief medical officer of Arcutis, the company behind ZORYVE, emphasized the focus on simplifying treatment for seborrheic dermatitis. The foam is well-tolerated with a favorable safety profile, and the incidence of adverse events was low and similar to that of the control group. The most common adverse reactions reported were nasopharyngitis, nausea, and headache.

Arcutis Biotherapeutics, Inc., the developer of ZORYVE, is a commercial-stage biopharmaceutical company dedicated to addressing the needs of individuals with immune-mediated dermatological diseases. The company's portfolio includes two FDA-approved products and a robust pipeline targeting a range of inflammatory dermatological conditions.

ZORYVE foam is indicated for the treatment of seborrheic dermatitis in both adult and pediatric patients aged nine and older. It is contraindicated for patients with moderate to severe liver impairment. The foam's propellants are flammable, so precautions should be taken to avoid fire, flame, and smoking during and immediately after application.