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Search / Trial NCT01368224

Two Supplemented Against Skin Reactivity

Launched by L'OREAL · Jun 6, 2011

Trial Information

Current as of June 22, 2025

Completed

Keywords

Skin Sensitivity Trans Epidermal Water Loss Clinical Score Skin Moisturization Factors Serum Immune Regulatory Cytokine Evaluation Of Intestinal Flora Composition

ClinConnect Summary

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...

Gender

FEMALE

Eligibility criteria

  • 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.

About L'oreal

L'Oréal is a global leader in the cosmetics and beauty industry, renowned for its commitment to innovation and research in skincare, haircare, and makeup products. As a clinical trial sponsor, L'Oréal prioritizes scientific rigor and ethical practices, conducting comprehensive studies to evaluate the safety and efficacy of its products. The company collaborates with leading researchers and institutions to advance the understanding of beauty science, ensuring that its offerings meet the highest standards of quality and effectiveness. L'Oréal's dedication to sustainability and social responsibility further underscores its mission to enhance the well-being of individuals while promoting responsible beauty practices worldwide.

Locations

Villeurbanne, , France

Patients applied

0 patients applied

Trial Officials

Frédéric BOUDJEMA, MD

Principal Investigator

Dermscan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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