Roflumilast Foam Aligns with Industry Standards for Seborrheic Dermatitis Care: Study

A recent study published in the Journal of Clinical and Aesthetic Dermatology supports the approved formulation of roflumilast foam, noting that its alignment with beauty industry standards and exclusion of harmful ingredients is important for the confidence of practitioners using the treatment in patients with seborrheic dermatitis (SD).

The current therapeutic landscape, according to the authors, includes topical antifungals and corticosteroids, which can cause side effects such as skin irritation, atrophy, and dyschromia, creating a need for novel therapies that effectively manage SD while minimizing side effects. Roflumilast foam, approved by the FDA in December 2023 for treating SD in individuals aged 9 years or older, represents a significant advancement, they said. Roflumilast foam's water-based formulation excludes fragrances and known irritants, matching the natural pH of the stratum corneum. It uses Crodafos CES, an emulsifying wax that prevents micelle formation, thus avoiding deposition on hair fibers and enabling effective scalp targeting. This ingredient also reduces lag time for medication absorption and is used widely in hair care products for its ability to enhance color retention and minimize cuticle damage.

The authors evaluated the formulation against beauty industry standards, and the results were reviewed by an expert dermatologist panel. The formulation excludes harmful ingredients like sulfates, dyes, and preservatives, aligning with the industry's emphasis on ingredient safety. Eight out of nine experts expressed high confidence in prescribing roflumilast foam to patients with diverse hair and skin types, including those with prior hair treatments.

"The alignment of roflumilast foam’s formulation with beauty industry standards and its validation by an expert dermatologist panel underscore its suitability for a diverse range of hair and skin types in the management of seborrheic dermatitis," the authors wrote in the conclusion. "The panel’s thorough review, which echoed the beauty industry’s emphasis on potentially harmful ingredients, reinforces the foam formulation’s safety profile. Ultimately, this novel foam emerges as a promising therapeutic option, offering effective and safe management of SD by leveraging familiar ingredients to enable the reliable delivery of a well-studied medication."

Source: Chovatiya R, et al. Journal of Clinical and Aesthetic Dermatology. 2024;17(5):30–33.