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Two Supplemented Against Skin Reactivity

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ClinicalTrials.gov Identifier: NCT01368224
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : June 7, 2011
Sponsor:
Collaborator:
Nestlé
Information provided by:
L'Oreal

Tracking Information
First Submitted Date  ICMJE June 6, 2011
First Posted Date  ICMJE June 7, 2011
Last Update Posted Date June 7, 2011
Study Start Date  ICMJE June 2004
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2011)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Supplemented Against Skin Reactivity
Official Title  ICMJE PLACEBO-CONTROLLED STUDY OF THE EFFECT OF TWO FOOD SUPPLEMENTS ON SKIN REACTIVITY
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Sensitivity
  • Trans-epidermal Water Loss
  • Clinical Score
  • Assessment of Skin Moisturization Factors
  • Assessment of Serum Immune-regulatory Cytokine
  • Evaluation of Intestinal Flora Composition
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Placebo Comparator: Maltodextrin
    Intervention: Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001
  • Experimental: Lactobacillus paracasei NCC 2461 (ST 11)
    1x1010 CFU of Lactobacillus paracasei NCC 2461 (ST 11)
    Intervention: Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001
  • Experimental: Lactobacillus paracasei+ Bifidobacterium longum
    1x1010 CFU of Lactobacillus paracasei NCC 2461 (ST 11) + 1x1010 CFU of Bifidobacterium longum (NCC3001)
    Intervention: Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2011)
96
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01368224
Other Study ID Numbers  ICMJE 1040341
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Audrey Gueniche, L'Oreal
Study Sponsor  ICMJE L'Oreal
Collaborators  ICMJE Nestlé
Investigators  ICMJE
Principal Investigator: Frédéric BOUDJEMA, MD DERMSCAN
PRS Account L'Oreal
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP