Abstract
BACKGROUND: Acne is a prevalent skin concern that has many therapies targeting the pilosebaceous unit. Data suggest there are underlying immuno-inflammatory drivers contributing to acne, with evidence for the efficacy of nutraceuticals including botanicals in targeting the key root causes. However, well-designed clinical studies on their efficacy and safety remain scarce. AIMS: The goal of this study is to determine the safety and efficacy of a novel oral nutraceutical in women with mild to moderate non-nodulocystic acne. METHODS: This 12-week randomized, double-blind, placebo-controlled trial evaluated the safety and efficacy of a nutraceutical addressing mild-to-moderate acne in adult women. Subjects were washed out of all acne products and provided with a standardized skin regimen and randomized into active or placebo groups. The primary endpoint was the change in Investigator Global Assessment (IGA) of acne severity at week 12. Additional endpoints included improvements in inflammatory and non-inflammatory lesion counts and blinded investigator skin assessments. RESULTS: A total of 102 women were enrolled in the study, with 92 subjects completing the study (47 active; 45 placebo). Compared to placebo, subjects taking the supplement along with the same standardized skin care regimen saw significant improvements in IGA scores, and a higher percentage of them achieved clear/almost clear ratings. There were also significant decreases in both inflammatory and non-inflammatory lesions compared to baseline, and overall skin parameters significantly improved compared to placebo. CONCLUSION: The oral nutraceutical significantly improves mild-to-moderate acne and overall skin health in adult women when compared to a placebo. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT06097871.