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Skin Sensitivity clinical trials

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NCT ID: NCT01368224 Completed - Clinical trials for Trans-epidermal Water Loss

Two Supplemented Against Skin Reactivity

Start date: June 2004
Phase: Phase 3
Study type: Interventional

In recent decades, the incidence of subjects presenting reactive skin has considerably increased in industrialized countries. Probiotics are live microorganisms which, when ingested in sufficient amounts, have beneficial effects on human health. The mechanism underlying the effect of probiotics involves, in part, regulation of the composition and/or metabolic activity of the intestinal microbiota.. It is postulated that following interaction of probiotics with the intestinal epithelium, associated intestinal cells become activated and consequently mediators are released into the blood circulation. Mediators, activated intestinal epithelial cells and possibly bacterial fractions might reach the skin through the bloodstream where they potentially could exert effects.The objective of this study was to assess the effects of probiotics on reactive skin symptoms. The strain Lactobacillus paracasei NCC2461 was tested alone and in combination with the strain Bifidobacterium longum NCC3001 in a randomized, double-blind study. The two strains were selected for their immune-modulatory properties demonstrated in in vitro and other preclinical studies as well as in a pilot clinical trial. Ninety-six women presenting reactive skin were randomized to 3 groups: placebo (n = 32), L. paracasei NCC2461 alone (n = 32) and L. paracasei NCC2461 + B. longum NCC3001 (n = 32). The supplements were administered by the oral route for 58 days (1010 CFU/day). The objective of the clinical trial was to determine, in vivo, the effect of food supplements on reactive skin symptoms (as measured by skin sensitivity and the reconstruction of barrier function post-repeated tape stripping). The secondary objectives were to determine the effect of the food supplements on leg skin dryness and facial skin roughness and the associated biochemical, immunological and microbiological factors. Accordingly, the subjects' skin sensitivity was determined by the capsaicin test. The reconstruction of barrier function was determined by measuring the trans-epidermal water loss (TEWL) post-repeated stripping using a SERVOMED evaporimeter. A clinical score for skin dryness and roughness was assigned by a dermatologist. The subjects also assessed their leg and facial skin dryness themselves. Each analysis was conducted at the various time points. In parallel, assessment of the skin moisturizing factors and serum inflammatory and immune-regulatory cytokines were performed. Finally, key components of the intestinal microbiota were analyzed.