Trans-epidermal Water Loss Clinical Trial
Official title:
PLACEBO-CONTROLLED STUDY OF THE EFFECT OF TWO FOOD SUPPLEMENTS ON SKIN REACTIVITY
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05711303 -
Study to Investigate the Effect of Superba Boost on the Skin
|
N/A |