ORLANDO -- A spray containing ammonia-oxidizing bacteria offered a safe and effective treatment for improving the appearance of skin afflicted with keratosis pilaris, researchers said here.
After 4 weeks, a two-point favorable change in the Investigator Global Assessment (IGA) -- complete clearance of keratosis pilaris -- was observed in nine of 24 arms (38%) treated with topical Nitrosomonas eutropha, and in three of 24 arms (13%) treated with a placebo spray for a statistically significant difference (P=0.03), said of Skin Care Physicians in Chestnut Hill, Mass.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Overall, 18 of 24 patients reported improvements versus placebo, Lee said in a presentation at the American Academy of Dermatology annual meeting.
When compared to baseline, all patients reported an improvement in their condition at 2 weeks and at 4 weeks, she added.
"The spray was effective in improving the cosmetic appearance and texture of keratosis pilaris when used twice daily," she said. "More than 90% of the patients reported satisfaction with the treatment."
Some degree of keratosis pilaris affects up to 40% of the American population, Lee explained. Her group worked off the "hygiene hypothesis" -- that better bathing facilities and the proliferation of skin care products has created losses in endogenous skin protection, and possibly the loss of mechanisms that protect against conditions such as asthma, eczema, and keratosis pilaris.
The ammonia-oxidizing bacteria spray is designed to return the skin to its normal microbiome, which may prevent keratosis pilaris from erupting in papules on body surfaces, usually the arms, legs and trunk.
The patients in the study were told to spray one side of their body with the novel agent twice a day.
The authors reported that skin smoothness, evaluated with 3D imaging, showed "impressive improvement (>45% reduction versus placebo in Knots Total Count and Knots Total Area)."
Lee's group performed polymerase chain reaction (PCR) testing, and determined the presence of the ammonia-oxidizing bacteria on the participants's skin after using the spray. They also found some degree of the bacteria on the other arm that was not treated, possibly due to cross-contamination.
Lee said the latter finding on the untreated arm may explain finding improvements on the placebo side.
AAD session moderator of Oregon Medical Research Center in Portland, told 鶹ý, "This is very interesting, isn't it? Adding bacteria to treat a skin disease. This is an interesting concept. Dr. Lee gave a good background about the hygiene hypothesis."
But he cautioned that there is still a lot of work to be done before the treatment should be used routinely.
Disclosures
The trial was supported by AOBiome.
Lee disclosed relevant relationships with AOBiome.
Blauvelt disclosed relevant relationships with AbbVie, Amgen, Boehringer Ingelheim Pharma, Dermira, Genentech, Genzyme, GlaxoSmithKline, Glenmark, Janssen-Ortho, Eli Lilly, Merck, Novartis, Regeneron, Sun Pharmaceuticals, and Valeant Pharmaceuticals.
Primary Source
American Academy of Dermatology
Lee N, et al "Improving the appearance of keratosis pilaris with ammonia oxidizing bacteria" AAD 2071; Abstract 5143.