Open-Label, Prospective Study of a Prebiotic Gel Cream on Its Efficacy of Mild to Moderate Acne Management and...

Acne vulgaris is a chronic inflammatory condition, which is estimated to affect greater than 85% of the population. Acne is a multifactorial condition, which can be influenced by diet, environment, and the microbiome.

The purpose of this clinical study is to assess the safety and effects of a prebiotic-containing gel cream on the skin microbiome of individuals with non-cystic acne-prone skin.

In this 7-week clinical trial, 30 eligible participants were recruited and enrolled from the Sacramento region. The study consisted of three visits: (1) screening; (2) week 0, baseline; (3) week 6. All participants received a standard non-comedogenic cleanser and a prebiotic-containing gel cream. The primary endpoint in this study was alteration in C. acnes abundance in mild to moderate non-cystic, acne-prone skin. The secondary endpoint in this study was functional gene analysis for skin barrier and skin inflammation-related genes from whole genome sequencing of the skin microbiome.

Acne lesions significantly reduced in non-inflammatory lesions, inflammatory lesions, and total lesions after treatment (-36.0%, -34.5%, and -35.9%, respectively). On the glabella, there was a 12.5 log2 fold increase in abundance of a healthy strain of C. acnes that is not associated with acne vulgaris. Furthermore, there was a wide range of functional bacterial genetic changes that may be associated with increased collagen and glutathione production. The gel cream was rated very well tolerated, and there were no adverse effects reported.

This prebiotic-containing gel cream can be an effective form of management for acne vulgaris by creating beneficial shifts in the skin microbiome.