Development of a topical bacteriophage gel targeting Cutibacterium acnes for acne prone skin and results of a phase 1 cosmetic randomized clinical trial

作者：M. Golembo, S. Puttagunta, U. Rappo, E. Weinstock, R. Engelstein, I. Sass, A. Moses, E. Kario, E. Cohen, J. Nicenboim, H. David, K. Sudakov, A. Cohen, M. Bassan, N. Zak, N. Zak, BiomX, Ltd. · 发表于：Skin Health and Disease · 年份：2022 · DOI：10.1002/ski2.93 · 被引用次数：34 · 研究领域：Medicine

Abstract Background Topical antibiotics are frequently used to treat acne vulgaris. Their prolonged use, often for longer durations than recommended, has led to antibiotic resistance in Cutibacterium acnes (C. acnes), a bacterium implicated in acne pathophysiology. Bacteriophage (phage), which specifically target C. acnes by a different mechanism of action and do not harm potentially beneficial bacteria, may offer an alternative approach for improvement of the appearance of acne prone skin. Objectives To identify and characterize C. acnes targeting phage, carry out a comprehensive preclinical safety evaluation of phages selected for further development and examine their safety, tolerability and ability to target facial C. acnes when applied topically in a cosmetic clinical study including participants with mild‐to‐moderate acne. Methods Phages were isolated by conventional microbiological methods also used to examine their breadth of host range on different C. acnes strains and specificity to this bacterial species. Safety assessment of three selected phages was carried out by complete genomic analysis to assure the absence of undesired sequences and by ex vivo models employed to evaluate the safety, irritability and potential systemic bioavailability of phage applied topically. A randomized, controlled clinical study assessed safety, tolerability and efficacy in targeting facial C. acnes. Results Wide host range phages that also target antibiotic resistant C. acnes were iden...