Trans-epidermal Water Loss Clinical Trial
Official title:
PLACEBO-CONTROLLED STUDY OF THE EFFECT OF TWO FOOD SUPPLEMENTS ON SKIN REACTIVITY
| Verified date | June 2011 |
| Source | L'Oreal |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| 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.
| Status | Completed |
| Enrollment | 96 |
| Est. completion date | March 2006 |
| Est. primary completion date | March 2006 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 35 Years |
| Eligibility |
Inclusion Criteria: - Healthy subject. - Gender: female. - Subject aged more than 18 years and less than 35 years (inclusive) - Phototype: I to IV - Caucasian race. - For women of child-bearing potential, effective contraception for at least 12 weeks and maintained throughout the study and for 1 month after completion of the study. - Sensitive skin: (1) as per the subjective evaluation questionnaire in appendix 12.2. (with at least 1 positive response to one of the first 3 questions) and (2) responder to the capsaicin test at one of the 3 lowest concentrationsSubject known to have dry leg skin (clinical score of at least 2 as per the scale). - Subject known to have rough cheek skin (clinical score of at least 3 as per the scale). - Low consumers of fermented dairy products (less than 125 g/d) and agreeing not to eat fermented dairy products containing live bacteria (yogurt, cottage cheese, fermented dairy products, unpasteurized cheese, etc.) for the duration of the study. Exclusion Criteria: - Post-menopausal woman. - Pregnant or breast-feeding woman or woman planning pregnancy during the study. --Volunteer with a skin disease in the test areas (particularly acne rosacea). Volunteer presenting a stable or progressive serious disease (investigator's assessment). - Immunocompromised subject. - Subject allergic to one of the constituents of the test products and, in particular, capsaicin or pepper. - Alcohol intake greater than 2 glasses of wine daily or 1 glass of liquor daily. - Smoker of more than 6 cigarettes/day. - Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment). - Subjects regularly practicing aquatic or nautical sports. - Subjects regularly attending a sauna. - Subject with cardiovascular or circulatory history. - Subject with a history of skin cancer or malignant melanoma. - Subject with a history of intestinal surgery. - Intake of antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants. - Subject practicing sports for more than 5 hours per week. - Subject having taken mineral or vitamin supplements in the 3 months preceding the study (investigator's assessment). - Lacto-ovo-vegetarian, vegetarian. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | DERMSCAN - PharmaScan | Villeurbanne |
| Lead Sponsor | Collaborator |
|---|---|
| L'Oreal | Nestlé |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | skin sensitivity and skin barrier reconstruction | determining the effect of food supplements on skin reactivity (measured by skin sensitivity and the skin barrier function reconstruction after repeated tape-stripping). | No | |
| Secondary | dryness , roughness, biochemical factors and safety | determining the effect of the food supplements on leg skin dryness and facial skin roughness, determining the effect of the food supplements on the associated biochemical and immunological factors, Evaluating the safety of the study products. |
Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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