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Clinical Report

Safety and Efficacy of Topically Applied Selected Cutibacterium acnes Strains over Five Weeks in Patients with Acne Vulgaris: An Open-label, Pilot Study

Ante Karoglan, Bernhard Paetzold, Joao Pereira De Lima, Holger Brüggemann, Thomas Tüting, Denny Schanze, Marc Güell, Harald Gollnick
DOI: 10.2340/00015555-3323

Preview of fully accepted paper, still not published in any volume

Abstract

Imbalance in skin microflora, particularly related to certain Cutibacterium acnes strains, may trigger acne. Application of non-acne-causing strains to the skin may modulate the skin microbiome and thereby lead to a reduction in acne. This pilot study evaluates the safety and efficacy of microbiome modulation on acne-prone skin. The study had 2 phases: active induction (5% benzoyl peroxide gel, 7 days) and interventional C. acnes strains treatment (5 weeks). Patients were randomized to either topical skin formulations PT1 (2 strains of C. acnes Single Locus Sequence Typing [SLST] type C3 and K8, 50% each) or PT2 (4 strains of C. acnes SLST type C3 [55%], K8 [5%], A5 [30%] and F4 [10%]). Safety and efficacy was evaluated in 14 patients (PT1=8/14, PT2=6/14). Skin microbiome composition shifted towards study formulations. No untoward adverse events, visible irritation, or significant flare-up were observed. Non-inflamed lesions and skin pH were reduced. Comedone counts improved clinically with no deterioration in inflammatory lesions.

Significance

This open-label, pilot study enrolled men and women (18–23 years) with acne vulgaris. In 14 enrolled patients, skin microbiome composition shifted towards study formulations. No untoward tolerability, visible irritation, or significant flare-ups were observed. Non-inflamed lesions and skin pH were reduced. Modulation of Cutibacterium acnes towards the non-acne causing strains on the skin of patients with acne was safe. C. acnes was formerly thought to be the cardinal cause of acne; however, recently some, but not all, strains of C. acnes were found to be responsible. This microbiome modulation approach as therapy requires validation in future clinical studies.

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