Two Supplemented Against Skin Reactivity

NCT01368224 | Completed Phase 3 DMC

• 1 other identifier: 1040341
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Sensitivity; Trans-epidermal Water Loss; Clinical Score; Assessment of Skin Moisturization Factors; Assessment of Serum Immune-regulatory Cytokine; Evaluation of Intestinal Flora Composition

Keywords

Skin sensitivity; Trans-epidermal water loss; Clinical score; skin moisturization factors; serum immune-regulatory cytokine; Evaluation of intestinal flora composition

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• dryness , roughness, biochemical factors and safety

Study Arms (3)

Maltodextrin

PLACEBO COMPARATOR

Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001

Lactobacillus paracasei NCC 2461 (ST 11)

EXPERIMENTAL

1x1010 CFU of Lactobacillus paracasei NCC 2461 (ST 11)

Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001

Lactobacillus paracasei+ Bifidobacterium longum

EXPERIMENTAL

1x1010 CFU of Lactobacillus paracasei NCC 2461 (ST 11) + 1x1010 CFU of Bifidobacterium longum (NCC3001)

Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001

Interventions

Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001 DIETARY_SUPPLEMENT

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.

Lactobacillus paracasei NCC 2461 (ST 11); Lactobacillus paracasei+ Bifidobacterium longum; Maltodextrin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• L'Oreal: lead
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

DERMSCAN - PharmaScan

Villeurbanne, 69623, France

Location

Study Officials

• Frédéric BOUDJEMA, MD

  Dermscan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Study Start: June 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: June 7, 2011

Record last verified: 2011-06

Locations

FR (1)