Data Suggest Roflumilast Cream Vehicle Has Similar Moisturizing Properties as Commercial Moisturizer in Treating Mild Eczema

New data demonstrate that the proprietary cream vehicle used in roflumilast has similar moisturizing properties as a commercially marketed, dermatologist-recommended, ceramide-containing moisturizer in adults with mild eczema, according to a press release from Arcutis Biotherapeutics.

Atopic dermatitis and other forms of eczema have underlying skin barrier defects, which can be exacerbated by topical medications that damage the skin barrier. According to Arcutis Biotherapeutics, the cream vehicle found in roflumilast was designed with both 50% water content and an ultra-mild emulsifier. It was also designed without propylene glycol, polyethylene glycol, ethanol, or fragrance.

“In this study, both the Arcutis cream vehicle and a dermatologist-recommended, ceramide-containing moisturizing cream were well received by patients, with patients reporting improvements in dryness, redness, irritation, and other skin characteristics, as well as positive feedback on the aesthetic properties of the 2 creams,” said Zoe Diana Draelos, MD, president and principal investigator at Dermatology Consulting Services, in the press release.

The intraindividual, single-site, randomized, double-blinded trial included 40 patients with mild asteatotic eczema. Patients applied either the roflumilast vehicle cream without the active ingredient roflumilast or the ceramide-containing moisturizer. Participants applied the cream to their lower legs and the study was randomized by leg, with each subject receiving the ceramide-containing moisturizer or the roflumilast cream vehicle on opposite legs.

Researchers found no statistically significant change from baseline in transepidermal water loss (TEWL) at day 15 in either group, suggesting that no skin barrier damage was caused by either the vehicle or the moisturizer. TEWL is the most widely-used objective measurement of skin barrier function and it can be used as an objective analysis of irritancy potential or protective properties of topical products, according to Arcutis Biotherapeutics.

The researchers noted that patients rated the roflumilast cream vehicle positively and said it was comparable to the ceramide-containing moisturizer. Specifically, the researchers found similar improvements in dryness, redness, roughness, tightness, irritation, moisturization, smoothness, and overall skin appearance between the 2 products.

Furthermore, patients consistently rated the aesthetic properties, such as spreadability, speed of absorption, feel of skin, and smell, comparably between the 2 products. Investigators assessed erythema, desquamation, roughness, and dryness, and also noted improvements for both treatments at all timepoints.

“As a clinician, I was impressed by the moisturizing properties of the Arcutis vehicle,” Draelos said in the press release.

REFERENCE

Arcutis Announces Data Comparing the Vehicle in Investigational Roflumilast Cream Against a Commercial Ceramide-Containing Moisturizing Cream. News release. Arcutis Biotherapeutics; December 13, 2021. Accessed January 14, 2022. https://www.arcutis.com/arcutis-announces-data-comparing-the-vehicle-in-investigational-roflumilast-cream-against-a-commercial-ceramide-containing-moisturizing-cream/