A Phase 2, Double-Blind, Randomized, Placebo-Controlled Trial of a Novel Nutritional Supplement Product to Promote Healthy Skin
October 2011 | Volume 10 | Issue 10 | Original Article | 1106 | Copyright © October 2011
Steven H. Dayan MD,a,b John P. Arkins BS,c Vinny Sharma BS,d Elaine Paterson PhD,e David Barnes PhDf
aChicago Center for Facial Plastic Surgery bClinical Assistant Professor of Otolaryngology at University of Illinois at Chicago cResearch Coordinator, DeNova Research dLake Erie College of Osteopathic Medicine eManger of Clinical Research, Standard Process fDirector of Research, StandardProcess
Background: Despite an abundance of nutritional supplements, very few well-controlled trials have assessed their beneficial effect on the skin, such as hydration, antioxidant levels, texture or appearance. The objective of the following placebo-controlled, double-blind study was to determine the effects of the Skin Health Experimental Product (SHEP) on skin health.
Methods: The study enrolled healthy men and women aged 30 years or older. Subjects were randomized to receive a twice-daily regimen of SHEP or placebo. The effects SHEP had on overall skin appearance and health were assessed by measuring improvements in: (1) skin hydration using a closed-aperture transepidermal water-loss moisture meter and a vapometer; (2) skin texture using silicon profilometry; (3) skin carotenoid concentration using Raman spectrometry; and (4) reported self-image assessments using the Global Aesthetic Improvement Scale (GAIS).
Results: SHEP-treated subjects demonstrated a significant reduction in fine lines compared to the placebo-treated group. Raman spectroscopy showed that SHEP increased carotenoids at some measurement sites. Based on the GAIS, SHEP-treated subjects were three times more likely to perceive an improvement in their appearance compared to placebo-treated subjects (P>0.049).
Conclusion: The orally-administered SHEP nutritional supplement improves skin texture, carotenoid levels in specific areas of the hand, and improves patients' perception of skin health.
J Drugs Dermatol. 2011;10(9):1106-1114.