A 12-week, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of a Nutraceutical Supplement for Mild to Moderate Non-cystic Acne in Young Adults.

Abstract

Background: Acne vulgaris is a chronic, inflammatory skin disease of the pilosebaceous unit frequently cited as the most common condition diagnosed and treated by dermatologists. Among the many therapies developed for treating acne, none are effective for all patients and new treatments are always being sought. A commercial nutraceutical formulated with vitamins, minerals and a proprietary blend of botanicals has been used as a safe and effective adjunctive therapy for non-cystic acne (Clear Skin Formula; VitaMedica®).

Objective: The objective of this study was to evaluate the safety and efficacy of this nutraceutical for treating non-cystic acne.

Methods: Subjects randomly received study product (n=26) or placebo capsules (n=14) which were taken daily for 84 days.

Results: Treatment with the nutraceutical supplement decreased mean (SD) inflammatory lesions counts from 21.4 (9.3) to 10.4 (8.1) (p=0.0001), decreased non-inflammatory lesion counts from 35.0 (17.1) to 19.5 (13.2) (p<0.0001) versus nonsignificant changes for placebo-treated subjects. Mean baseline IGA scores improved by nearly 1 grade from 2.3 (0.5) to 1.4 (0.6) after 84 days of treatment (p<0.0001) versus no change for subjects treated with placebo. The clinical improvements corresponded with significant improvements in acne-related quality of life measures. The nutraceutical supplement was well-tolerated.

Conclusion: These results demonstrate this nutraceutical to be safe and effective adjunctive therapy for patients with non-cystic acne. ClinicalTrial.gov Identifier NCT05879406.