Safety Evaluation of Topical Products Containing Live Cultures and Ferment of Cutibacterium Acnes Subspecies Defendens Strain XYCM42 in Individuals Predisposed to Acne Vulgaris.

BACKGROUND

For individuals with acne-prone skin, identifying a topical regimen that does not lead to progression of their inflammatory issues often poses a challenge. A topical skin probiotic regimen containing a specific strain of subspecies , XYCM42, has been shown to be beneficial in improving skin health and appearance in individuals with generally healthy skin, but the use of the skin probiotic has not been sufficiently assessed in individuals with acne-prone skin.

OBJECTIVE

The purpose of this study was to evaluate the safety and efficacy of daily application of a topical skin biome care regimen containing a living subsp. derivative strain, XYCM42, its ferment, and adjunct topicals in individuals with acne-prone skin.

METHODS

This eight-week study was conducted at five locations and included 136 total participants. At baseline, Week 1, Week 4, and Week 8, subjects completed product questionnaires and symptom severity surveys. Of the study subjects, 20 were enrolled for clinical efficacy evaluation at all timepoints. Clinical assessments included blemish lesion counts, Investigator's Global Assessment (IGA) of acne lesion severity, and clinical grading of skin cosmetic and safety parameters.

RESULTS

As early as Week 1 of regimen application, clinical observations demonstrated statistically significant improvements in acne severity scores, with no subjects reporting increased or worsened acne during the study. By Week 4, subjects showed significant changes in nearly all skin cosmetic parameters assessed, including skin texture, clarity, tone, fine wrinkling, undereye dark circles, dryness, and erythema. Lesion counts were significantly reduced from baseline at all timepoints, with 100 percent of subjects experiencing fewer non-inflammatory lesions and 70 percent and 30 percent with fewer papule and pustule inflammatory lesions, respectively, by the end of the study. No adverse events were reported.

CONCLUSION

This at-home use study demonstrates that use of the XYCM42-based topical skin biome care regimen is both safe and appropriate for individuals with acne-prone skin. More broadly, the outcomes of this study provide further support toward the beneficial and commensal nature of subsp. in promoting skin health.