A multicenter, placebo-controlled, double-blind clinical trial assessing the effects of a multicomponent nutritional supplement for treating photoaged skin in healthy women

J Cosmet Dermatol. 2017 Mar;16(1):120-131. doi: 10.1111/jocd.12290. Epub 2016 Oct 25.

Abstract

Background: Dietary or supplementary intake of nutrients and other ingredients positively affects skin appearance.

Aims: Evaluate a multicomponent nutritional supplement on photoaged skin.

Patients/methods: This multicenter, double-blind, placebo-controlled trial randomized healthy 35- to 65-year-old women with Fitzpatrick skin types I-IV and Glogau classification types II-III to a multicomponent nutritional supplement or placebo for 24 weeks. The primary endpoint was Investigator Global Assessment of overall facial appearance at week 24. Secondary endpoints included investigator- and subject-rated assessments of the face, décolletage, and hands; facial photography assessments (conducted by an independent panel of dermatologists); and instrumental measures. Analysis of variance was used to assess between-group differences (P ≤ 0.05).

Results: Of 194 randomized subjects, 171 completed the study. Subjects had a mean age of 53 years and were primarily white (81%), had Glogau II (58%) and Fitzpatrick III (45%; significantly more supplement subjects had Fitzpatrick III [54%] vs. placebo [35%]; P = 0.039). At week 24, Investigator Global Assessment of overall facial appearance was numerically but not statistically better for supplement over placebo (mean difference: 0.14 [95% confidence interval: -0.16-0.44]; P = 0.358). A significant treatment-by-site interaction (P = 0.073) was observed; by-site analyses revealed a significant difference at one of three geographical sites for supplement vs. placebo (P = 0.001). Differences on secondary endpoints were generally not significant.

Conclusions: In the first multicenter study conducted with this multicomponent nutritional supplement, no significantly greater effects vs. placebo were observed on the primary endpoint, perhaps because of significant between-site variability.

Keywords: antioxidants; dietary supplement; marine complex; photoaging.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Dietary Supplements* / adverse effects
  • Double-Blind Method
  • Face
  • Female
  • Hand
  • Humans
  • Middle Aged
  • Neck
  • Photography
  • Skin Aging / drug effects*
  • Treatment Outcome