Status:
COMPLETED
Placebo-controlled Assessment of the Effect of a Food Supplement on Skin Protection After Exposure to UV Radiation
Lead Sponsor:
L'Oreal
Collaborating Sponsors:
Société des Produits Nestlé (SPN)
Conditions:
Photobiology
Eligibility:
MALE
20-40 years
Phase:
PHASE1
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...
Detailed Description
Langerhans cells (LC), the dendritic cells (DC) from epidermis, constitute the first line of immune defense against environmental attacks. Under steady state conditions, LC turnover is very low. The L...
Eligibility Criteria
Inclusion
- 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.).
Exclusion
- 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.
- Antibiotic, corticosteroid, non-steroidal anti-inflammatory or immunosuppressant intake.
- Strenuous sports (\> 5 hours per week) or naturism.
- Subject having taken a course of mineral supplements or vitamins in the 3 months preceding study initiation.
- Vegetarian or vegan diet.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2004
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00351689
Start Date
January 1 2004
End Date
July 1 2004
Last Update
October 3 2012
Active Locations (1)
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1
Dermscan
Lyon Villeurbane, France, 69 603