Effect of Topical Microencapsulated Benzoyl Peroxide on the Skin Microbiome in Rosacea: A Randomized, Double-Blind, Crossover, Vehicle-Controlled Clinical Trial.

Objective: We sought to evaluate changes in microbiome biodiversity and physical properties of the skin after eight weeks of once-daily topical microencapsulated benzoyl peroxide (E-BPO) compared to vehicle cream in participants with rosacea.
Methods: This was a randomized, double-blind, crossover, single-center, vehicle-controlled evaluation of E-BPO on the skin microbiome in rosacea. Participants had facial rosacea with global severity of 3 or 4 on the Investigator Global Assessment (IGA) scale. In the Treatment 1-2 group, participants received E-BPO for eight weeks then switched to vehicle cream for four weeks. In the Treatment 2-1 group, participants received vehicle cream for eight weeks, then E-BPO for four weeks.
Results: Thirty-one participants were enrolled and randomly assigned to either group. Demographic characteristics were comparable between the treatment groups. After eight weeks of E-BPO treatment, there was a marked reduction in the relative abundance of Staphylococcus accompanied by an increase in Cutibacterium . At the species level, there was an increase in the relative abundance of C. acnes and a decrease in abundance of S. epidermidis . No noticeable difference was detected at the genus or species level at Week 8 in the 2-1 group. Sebum level, IGA, lesion counts, facial erythema, and inflammatory scores were improved with E-BPO versus vehicle cream. Adverse events were mild or moderate in severity.
Limitations: The study included a small number of subjects and only surface-swabs were used for microbiome sampling.
Conclusion: E-BPO shifted the skin microbiome in rosacea and demonstrated improvements in clinical symptoms and skin physical properties and a well-tolerated safety profile. US National Library of Medicine; Trial ID: NCT05675501]; URL: clinicaltrials.gov.
Competing Interests: DISCLOSURES: Dr. Sivamani serves as a scientific adviser for LearnHealth, Arbonne, and Codex Labs and as a consultant to Burt’s Bees, Novozymes, Nutrafol, AbbVie, Sanofi, Fotona, Incyte, Leo, UCB, Novartis, Bristol Myers Squibb, Lilly, Sun, Pfizer, Almirall, and Regeneron Pharmaceuticals. Dr. York is an employee of Galderma Laboratories, L.P. Dr. Sugarman is a consultant and speaker for Pfizer, Regeneron, Sanofi, and Incyte; a consultant for Bausch Heath and Sol-Gel; and a medical safety monitor for Galderma clinical research trials. Dr. Gallo is a co-founder, scientific advisor, consultant and has equity in MatriSys Biosciences. Dr. Levy-Hacham and Ms. Mizrahi are employees of Sol-Gel Technologies.
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