Expert Panel Confirms Efficacy and Safety of Roflumilast Topical Foam for Seborrheic Dermatitis Across Diverse Hair Types

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In a recent publication in the Journal of Clinical and Aesthetic Dermatology, Arcutis Biotherapeutics, Inc. announced the validation of roflumilast (Zoryve) topical foam, 0.3% for the treatment of seborrheic dermatitis across diverse hair types. This validation comes after a comprehensive evaluation by an expert dermatologist panel, shedding light on the formulation's efficacy and safety.¹

“Seborrheic dermatitis is a common inflammatory skin condition that can affect individuals across all ages and demographics, and a spectrum of hair types. In addition, certain hair care practices can exacerbate the severity of the symptoms or complicate treatment options. As such, there is a significant need for versatile and well tolerated treatment options that do not interfere with the natural properties of hair and can effectively deliver therapeutic drug to the affected area including hair-bearing areas such as the scalp, or other areas of skin,” said Raj Chovatiya, MD, PhD, associate professor at the Rosalind Franklin University Chicago Medical School, founder and director of the Center for Medical Dermatology and Immunology Research, Dermatology Times Fall 2024 Editor in Chief, and lead author of the publication, said in a press release. “These findings highlight that the ZORYVE foam formulation excludes harmful ingredients that are known to damage hair and includes a gentle emulsifier used for the first time in the pharmaceutical industry, which provides confidence in its use for patients without damaging the skin barrier or hair styles.”

The formulation review highlighted key attributes of roflumilast foam that make it well-suited for diverse hair and skin types. Notably, the exclusion of harmful ingredients commonly found in topical treatments, such as thickening agents, alcohol, fragrances, essential oils, and oxidizing agents, sets roflumilast foam apart. Additionally, Arcutis innovatively incorporated Crodafos CES, a gentle emulsifier previously used in the skin and beauty industry, into the formulation, further enhancing its compatibility across skin and hair types.

The validation of roflumilast foam by a panel of expert dermatologists, comprising both medical and cosmetic specialists, reinforced its suitability for a wide range of patients. Of the 9 experts consulted, 8 expressed "extreme confidence" in prescribing roflumilast foam to patients with diverse skin and hair characteristics, including those with a history of previous hair treatments. This endorsement reflects the formulation's efficacy and safety profile, as well as its potential to address the unmet needs of patients with seborrheic dermatitis.

Patrick Burnett, MD, PhD, chief medical officer of Arcutis, highlighted the patient-centric approach taken in formulating roflumilast foam. By prioritizing attributes such as once-daily application, water-based formulation, and exclusion of known irritants like fragrances, Arcutis aimed to develop a treatment that not only effectively manages seborrheic dermatitis but also enhances patient comfort and compliance. He said, “We are pleased to see such a strong endorsement from the expert dermatological panel, who bring their medical and cosmetic expertise from clinical practice and research, on the formulation qualities of ZORYVE foam that make it compatible with all hair and skin types for the treatment of seborrheic dermatitis.”

Roflumilast topical foam was approved for patients ages 9 and older by the US Food and Drug Administration for this indication in December 2023, making the once-daily steroid-free foam the first drug approved for seborrheic dermatitis in more than 2 decades. In the roflumilast foam-treated group of the pivotal phase 3 STRATUM study (NCT04973228), almost 80% of patients successfully met the primary efficacy endpoint of IGA Success by week 8, with slightly over 50% achieving complete clearance.²

Read more from Dermatology Times about the clinical research leading to approval here.

References

1. Expert panel review further validates use of ZORYVE® (roflumilast) topical foam, 0.3% for treatment of seborrheic dermatitis across diverse hair types published in Journal of Clinical and Aesthetic Dermatology. News release. Arcutis Biotherapeutics. May 13, 2024. Accessed May 13, 2024. https://www.arcutis.com/expert-panel-review-further-validates-use-of-zoryve-roflumilast-topical-foam-0-3-for-treatment-of-seborrheic-dermatitis-across-diverse-hair-types-published-in-journal-of-clinical-and-aestheti/
2. Andrus E. Roflumilast foam, 0.3% for seborrheic dermatitis launches in US. Dermatology Times. January 22, 2024. Accessed May 13, 2024. https://www.dermatologytimes.com/view/roflumilast-foam-0-3-for-seborrheic-dermatitis-launches-in-us