Placebo-controlled Assessment of the Effect of a Food Supplement on Skin Protection After Exposure to UV Radiation

NCT00351689 | Completed Phase 1 DMC

• 1 other identifier: 1030740
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A probiotic bacterial strain was tested in a randomized, double blind , placebo controlled clinical trial with 54 healthy male volunteers. Half the volunteers received the dietary supplement the other half placebo during 6 weeks prior to exposure to solar-simulated UV irradition (2x1,5MED). Blister roofs and skin biopsies were recovered 1, 4 and 10 days after UV exposure from unirradiated and irradiated skin and used for immunohistochemical analysis and mixed epidermal cell lymphocyte reaction

Conditions

Photobiology

Keywords

Probiotic bacteria; cutaneous immune homeostasis; UV radiation; dietary supplement

Outcome Measures

Primary Outcomes (1)

• Evaluation of food supplement effect on the functions of epidermal cells after UV radiation exposure.

Secondary Outcomes (1)

• Qualitative analysis (activation and/or maturation status) of cutaneous Langerhans cells and macrophages and analysis of their location and Evaluation of the erythema, pigmentation after UV exposure, Evaluation of safety.

Interventions

dietary supplement BEHAVIORAL

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subject
• Gender: male.
• Age: greater than 20 years and less than 40 years.
• Phototype: II or III.
• Subject having freely given his informed written consent.
• Cooperative subject, aware of the necessity for and duration of the controls, suggesting complete compliance with the protocol set up by Laboratoire DERMSCAN.
• Subject with Social Security coverage.
• A priori, a low fermented milk product consumer (less than 125 g/d) who, during the study, agrees not to eat fermented milk products containing live bacteria (yogurt, cream cheese, fermented dairy products, unpasteurized cheese, etc.).

You may not qualify if:

• Subject deprived of freedom by a court or administrative order.
• Minor or major protected by law.
• Subject residing in a health or social care establishment.
• Patient in an emergency setting.
• Subject presenting with skin disease on the test zones.
• Subject presenting with a stable or progressive serious disease (investigator's assessment).
• Immunocompromised subject.
• Subject allergic to one of the constituents of the test products or to xylocaine.
• Subject with a history of allergy to solar or UV radiation.
• Immoderate use of alcohol (more than 2 glasses of wine daily or more than 1 glass of spirits daily).
• Immoderate smoker (more than 6 cigarettes/day).
• Subject exposed to the sun or UV radiation in the last 3 months (facial exposure was authorized with use of a total-block sunscreen and sunglasses).
• Subject with cardiovascular or circulatory disease history.
• Subject with a history of skin cancer, malignant melanoma.
• Subject with a history of intestinal surgery.

Sponsors & Collaborators

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

Study Sites (1)

Dermscan

Lyon Villeurbane, 69 603, France

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• AUDREY GUENICHE, PhD

  L'Oreal

  STUDY DIRECTOR

• TIMO BUETLER, PhD

  Société des Produits Nestlé (SPN)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 13, 2006
• Study Start: January 1, 2004
• Study Completion: July 1, 2004
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

FR (1)