Expert Panel Validates ZORYVE® Foam for Seborrheic Dermatitis in Various Hair Types

Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company specializing in immuno-dermatology, has announced the publication of a comprehensive evaluation of ZORYVE (roflumilast) topical foam, 0.3%, by the Journal of Clinical and Aesthetic Dermatology (JCAD). ZORYVE foam is a once-daily steroid-free treatment designed for seborrheic dermatitis, intended for use across all hair and skin types.

Seborrheic dermatitis is a widespread inflammatory skin condition affecting a diverse demographic. It manifests as red patches with oily, yellow scales and is often itchy. This condition commonly affects areas of the body with sebaceous glands, such as the scalp, face, upper chest, and back. It is a chronic and recurrent disease, affecting up to 10 million people in the United States.

Raj Chovatiya, MD, PhD, MSCI, an associate professor at the Rosalind Franklin University Chicago Medical School and lead author of the publication, emphasized the need for versatile and well-tolerated treatments that do not interfere with hair properties. He highlighted that ZORYVE foam's formulation excludes harmful ingredients known to damage hair and incorporates a gentle emulsifier, Crodafos™ CES, used for the first time in the pharmaceutical industry. This provides confidence in its use for patients without damaging the skin barrier or hair styles.

A panel of expert dermatologists from various medical centers, dermatology clinics, and academic institutions across the United States reviewed the formulation of ZORYVE foam. Their assessment confirmed that the foam excludes harmful ingredients such as thickening agents, alcohol, fragrances, essential oils, and oxidizing agents. Arcutis stands out as the first company to incorporate Crodafos CES, an emulsifier recognized for its effectiveness across different skin and hair types, into a pharmaceutical product.

Following a thorough review of the formulation data, eight out of nine experts expressed high confidence in using ZORYVE foam for patients with various skin and hair types, including those who have undergone previous hair treatments. The foam's water-based formulation and exclusion of known irritants were noted as significant advantages for treating seborrheic dermatitis.

Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, expressed satisfaction with the panel's strong endorsement of ZORYVE foam. He emphasized that the foam was developed with the patient in mind, aiming for a once-daily application compatible with all hair and skin types.

In terms of its composition, ZORYVE foam is a topical formulation of roflumilast, a potent and selective phosphodiesterase-4 (PDE4) inhibitor. PDE4 is an enzyme linked to the production of pro-inflammatory mediators and the reduction of anti-inflammatory mediators, making it a well-established target in dermatology. ZORYVE foam represents the first new mechanism of action approved for seborrheic dermatitis in over two decades. It is indicated for treatment in both adult and pediatric patients aged nine years and older.

While ZORYVE foam provides a promising new treatment option, users should be aware of its safety information. It is contraindicated in patients with moderate to severe liver impairment. The foam's propellants are flammable, requiring caution around fire and open flames during application. Common side effects include nasopharyngitis, nausea, and headaches.

Arcutis Biotherapeutics is committed to addressing the needs of individuals living with immune-mediated dermatological conditions. With a growing portfolio that includes FDA-approved products, the company aims to provide differentiated therapies leveraging their expertise in dermatology.