New Roflumilast Vehicle Data Announced

The late-stage biopharmaceutical company, Arcutis Biotherapeutics, which is focused on developing innovations in immuno-dermatology, has announced new data from the Revolutionizing Atopic Dermatitis (RAD) Conference.¹

In the announcement, the proprietary cream vehicle had similar moisturizing properties as a commercially marketed, dermatologist-recommended, ceramide-containing moisturizer in adults with mild eczema, according to the release. The physician assessment of both tolerability and aesthetic improvement of patients found that the data from both groups were comparable.

Atopic dermatitis (AD) can be caused by underlying skin barrier defects, which can be further exacerbated by topical medications that harm the skin barrier, the release explained. The vehicle cream was designed by Arcutis with both 50% water content and an ultra-mild emulsifier at PH of the skin. It did not include 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. As a clinician, I was impressed by the moisturizing properties of the Arcutis vehicle,” said Zoe Diana Draelos, MD, president and principal investigator, Dermatology Consulting Services, PLLC, High Point, North Carolina.

The randomized, double-blinded, interindividual study data, which included 40 patients at a single site, was presented at the annual RAD Conference.

Patients with mild asteatotic AD were treated with either roflumilast vehicle cream, without the active ingredient roflumilast, or the ceramide-containing moisturizer to their lower legs. It was randomized with each patient receiving the ceramide-containing moisturizer and the Arcutis cream vehicle on opposite legs.

There was no statistically significant change from baseline in transepidermal water loss (TEWL) at day 15 with either treatment option. This suggests that no skin barrier damage was caused by either the vehicle or the moisturizer. The mean TEWL was comparable between roflumilast cream vehicle and the ceramide-containing moisturizer throughout the study after day 1.

The patients in the study rated the Arcutis cream vehicle positively and as comparable to the ceramide-containing moisturizer. Similar improvements in dryness, redness, roughness, tightness, irritation, moisturization, smoothness and overall skin appearance between both products were seen, according to the release.

Also, patients did consistently rate the aesthetic properties like spreadability, speed of absorption, feel of skin, and smell, comparably between the Arcutis cream vehicle and ceramide-containing moisturizer. For investigator assessments of erythema, desquamation, roughness, and dryness, improvements were observed for both treatments at all timepoints, the release continued.

“Arcutis is dedicated to bringing meaningful innovation to topicals, where limited innovation has occurred for many years,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, Westlake Village, California. “With 6 dermatology clinicians on staff, as well as 1 of the industry’s leading topical formulators, founder David Osborne, we have invested in developing therapies that may help address the trade-offs typically seen with many topical dermatology products.”

Reference:

1. Arcutis announces data comparing the vehicle in investigational roflumilast cream against a commercial ceramide-containing moisturizing cream. Globe Newswire. December 13, 2021. Accessed December 13, 2021. https://www.globenewswire.com/news-release/2021/12/13/2350723/0/en/Arcutis-Announces-Data-Comparing-the-Vehicle-in-Investigational-Roflumilast-Cream-Against-a-Commercial-Ceramide-Containing-Moisturizing-Cream.html