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A multicenter, placebo‐controlled, double‐blind clinical trial assessing the effects of a multicomponent nutritional supplement for treating photoaged skin in healthy women
Author(s) -
Birnbaum Jay E,
McDaniel David H,
Hickman Janet,
Dispensa Lisa,
Le Moigne Anne,
Buchner Larry
Publication year - 2017
Publication title -
journal of cosmetic dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.626
H-Index - 44
eISSN - 1473-2165
pISSN - 1473-2130
DOI - 10.1111/jocd.12290
Subject(s) - placebo , medicine , clinical endpoint , multicenter study , confidence interval , double blind , clinical trial , randomized controlled trial , mean difference , wrinkle , gerontology , alternative medicine , pathology
Summary 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.