A phase 2, double-blind, randomized, placebo-controlled trial of a novel nutritional supplement product to promote healthy skin

J Drugs Dermatol. 2011 Oct;10(10):1106-14.


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.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Carotenoids / metabolism*
  • Case-Control Studies
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Skin / drug effects*
  • Skin / metabolism
  • Spectrum Analysis, Raman
  • Treatment Outcome
  • Water Loss, Insensible


  • Carotenoids