Easing the itch: The skinny on topical nonsteroidal barrier repair

March 1, 2008

Early research suggests that nonsteroidal barrier repair creams might be worthwhile adjuncts in the treatment of atopic dermatitis.

Key Points

Detroit - New nonsteroidal barrier repair creams seem to be effective in helping to relieve atopic dermatitis (AD) symptoms, increase remission times and reduce dependence on topical steroids.

Approved by the United States Food and Drug Administration as medical devices for the treatment of AD, the three recently approved creams do not affect the structure or function of the body, do not achieve their intended uses through chemical reactions, and are not metabolized. Therefore, they did not have to go through the more rigorous FDA approval process for drugs.

The two creams on the market, palmitamide MEA(PEA)-containing cream (Mimyx, Stiefel Laboratories) and MAS063DP (Atopiclair, Graceway Pharmaceuticals), have limited but promising data behind them, according to Linda Stein Gold, M.D., dermatologist and director of clinical research at Henry Ford Hospital.

PEA-containing cream, a steroid-free, topical calcineurin inhibitor-free prescription therapy, has been shown to replenish deficient lipids in the skin, including a critical lipid called PEA, according to Dr. Gold.

"We know that PEA is deficient in atopic skin. This cream has been shown to add PEA, and it has anti-inflammatory properties," she says. "PEA-containing cream interacts with mast cells and modulates immune response."

In a study of about 2,500 subjects with AD, including 923 children, researchers incorporated Mimyx cream into the subjects' daily treatment regimens to determine whether adding Mimyx would improve AD signs and symptoms. (Eberlein-Koenig, et al. Improvement of signs and symptoms in PEA-containing cream-treated adults. Abstract submitted for presentation at: 64th Annual Meeting of the American Academy of Dermatology; March 2006; San Francisco, Calif.)

They found that adding the PEA-containing cream significantly improved itching, erythema, scaling, dryness, lichenification and excoriation.

The 38-day open study also found that the addition of Mimyx to AD treatment significantly improved sleep quality and was steroid-sparing, meaning patients used less steroids when they incorporated the PEA-containing cream into their daily regimen.

"At the start of the study, subjects reported applying close to eight applications of steroids each week and, at the end of the 38 days, they were only using three applications of the steroids each week," Dr. Gold tells Dermatology Times.

Other data on file with Stiefel Laboratories suggests that Mimyx, used along with an emollient in AD patients in remission, increases time between flares more than does using an emollient alone, and that the complete clearance of flares tends to be better achieved by Mimyx and a topical steroid than with a steroid alone, Dr. Gold says.

Atopiclair

Glycyrrhetinic acid in nonsteroidal topical MAS063DP inhibits the enzyme responsible for steroid metabolism and has also been shown to improve the skin's barrier function, not only preventing future flare-ups but also reducing the need for topical steroids.

In a multicenter, randomized, vehicle-controlled study of 218 subjects with mild to moderate AD, researchers looked at using the barrier cream alone versus vehicle alone for 50 days. (Abramovits W, Boguniewicz M, Kempers S, et al. J DrugsDermatol. 2006;5(3):236-244).

They reported a statistically significant improvement in Eczema Area and Severity Index (EASI) scores with the Atopiclair alone, as compared to vehicle alone.

"That study shows Atopiclair was significantly better at improving itch in as early as the first week," Dr. Gold says. "They also found that patients in the study needed less steroids as those on vehicle alone, and 92 percent of subjects in the study says they would opt to continuing using Atopiclair."

EpiCeram

Aminosterols, known as cationic steroid antibiotics, or CSAs, found in EpiCeram (Ceragenix Pharmaceuticals), have little in the way of research to prove AD efficacy. Nevertheless, one study comparing a 28-day treatment regimen of EpiCeram to a mid- potency topical steroid in children with moderate to severe AD found no statistically significant difference between the EpiCeram and the topical steroid Cutivate (PharmaDerm), Dr. Gold says.

"While these products do not yet take the place of topical steroids, it is nice that we have additional options to use in patients when we choose not to use topical steroids or topical immunomodulators or when we want to enhance our combination therapy and minimize topical steroid use," Dr. Gold says.

Disclosure: Dr. Gold is on the advisory board for Stiefel, Galderma, Novartis, Warner Chilcott and 3M. She is a consultant for Stiefel, Galderma, Novartis, Warner Chilcott and 3M, and has received honoraria from CollaGenex, Stiefel, Galderma, Novartis, Warner Chilcott and 3M.