Clinical Trial Testing Live Bacteria as Acne Treatment

(Kjerstin Michaela Haraldsen, Pixabay)

20 September 2016. A clinical trial is recruiting participants to test a product with live skin bacteria as a treatment for adult acne. The intermediate- and late-stage trial, testing a therapy made by biotechnology company AOBiome LLC in Cambridge, Massachusetts, is also using mobile devices with participants for remote data collection.

AOBiome develops skin care cosmetics and treatments seeking to reintroduce bacteria that oxidize ammonia eliminated from the skin microbiome through modern hygienic practices. Ammonia-oxidizing bacteria, says the company, convert ammonia and urea from perspiration to nitrite and nitric oxide. Nitrite helps control the growth of other microbes, including pathogens, while nitric oxide is a signaling molecule that helps regulate inflammation.

Acne, known medically as acne vulgaris, is a chronic inflammatory condition that blocks hair follicles and sweat glands, primarily on the face, chest and back, affecting some 80 million people in the U.S., according to data cited by the company. AOBiome says eliminating commensal or natural bacteria from the skin also removes the nitric oxide leaving the skin as a pro-inflammatory environment. The product tested in the clinical trial, code-named B244, is a topical spray that applies ammonia-oxidizing bacteria to the skin thus restoring the natural microbial balance controlling skin inflammations such as acne.

The intermediate- and late-stage clinical trial plans to recruit 372 individuals age 18 and older with mild to moderate cases of acne. Participants will be randomly assigned to spray either B244 or a placebo to the face twice a day for 12 weeks. The primary outcome measures for the study are counts of inflammatory acne lesions on the skin as well as improvement on a quality of life index scale. The trial is also evaluating the safety and tolerability of treatments, and measuring skin microbes on the face every 4 weeks.

The trial has another notable feature, the use of telemedicine for data collection. AOBiome is partnering with Science 37, a contract research organization in Culver City, California that offers remote data-gathering service known as Network Oriented Research Assistant, or Nora. The service connects clinical trial participants at their homes to Science 37, in this case to collect counts of acne lesions and other measures, with smartphones provided for the study. Previously, trial participants, or dermatology patients in general, would need to travel to doctors’ offices to evaluate progress.

AOBiome is testing B244 in clinical trials with other inflammatory conditions such as dermatitis, rosacea, and allergic rhinitis or hay fever. AOBiome is a 3-year old enterprise, whose founders include David Whitlock, an MIT-trained chemical engineer, who told the Boston Globe last year he hasn’t showed since the year 2000. Whitlock instead prefers to maintain microbial balance on his skin with the company’s consumer skin care products, marketed under the brand name Mother Dirt.

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