Trials / Completed

CompletedNCT01368224

Two Supplemented Against Skin Reactivity

PLACEBO-CONTROLLED STUDY OF THE EFFECT OF TWO FOOD SUPPLEMENTS ON SKIN REACTIVITY

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 96 (actual)

Sponsor: L'Oreal · Industry
Sex: Female
Age: 18 Years – 35 Years
Healthy volunteers: Accepted

Summary

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.

Detailed description

The probiotics and particularly Lactobacillus paracasei and Bifidobacterium longum are of value with respect to the homeostasis of dry and sensitive skin. An initial study (study report No. 1020813, DERMSCAN dated 2/10/2004) showed that the combination of L. paracasei NCC2461 (ST11) with Bifidobacterium lactis NCC2818 (Bb12) induced an improvement in certain parameters related to skin reactivity. However, the probiotics have not been tested separately. It was thus considered important to conduct a clinical trial aiming at confirming and documenting the data generated by the previous study and, also determining the specific efficacy of L. paracasei NCC2461 (ST11) on reactive skin symptoms. The latter probiotic strain was selected on the basis of its proven immune-modulatory properties (scientific dossier ST11-Nestec Benyacoub and Gueniche. Scientific evidence supporting the use of Lactobacillus paracasei NCC2461 (ST11) for Innéov. Report 11.02.2005 and references 23, 24, 31-33). The strain was combined or not with a probiotic of the Bifidobacterium genus, particularly Bifidobacterium longum NCC3001. The data generated by various preclinical studies (NRC in-house studies) and clinical studies (public) show that this probiotic strain is able to modulate immune mechanisms and could interfere with inflammatory reactions. Moreover, the probiotic combination concept enables providing potential benefit all along the gastrointestinal tract, inducing maintenance of an optimum intestinal flora.

Conditions

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001	1 treatment unit, in the form of a sachet of powder, to be reconstituted in a glass of water and taken once daily for 8 weeks (from D1 to D57), except if the last visit is bring forward or put back for no more than 3 days, in which case the subject will continue treatment until the final visit. Oral route.

Timeline

Start date: 2004-06-01
Primary completion: 2006-03-01
Completion: 2006-03-01
First posted: 2011-06-07
Last updated: 2011-06-07

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01368224. Inclusion in this directory is not an endorsement.