High Total Antioxidant Capacity Products Added to Diet (NCT00975728) | Clinical Trial Compass
CompletedPhase 3
High Total Antioxidant Capacity Products Added to Diet
Italy120 participantsStarted 2010-02
Plain-language summary
The purpose of this study is to evaluate the antioxidant activity on skin photo induced damage of a food supplement and its anti-age properties.
Who can participate
Age range30 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult volunteers of both sexes, between 30 and 60 years of age
* Phototype II or III ( Fitzpatrick's classification)
* Volunteers in a good general state of health in the Investigator opinion
* Volunteers not taking drugs or undergoing surgical procedure
* Volunteers who are giving a written informed consent
Exclusion Criteria:
* pregnancy
* lactation
* smoking \>10 cigarettes per day
* drinking more then one glass of wine per day
* drinking super-alcoholics
* assumption of food supplement
* change in the normal habits in the last month
* participation in a similar study during the previous 3 months
* insufficient adhesion to the study protocol
* dermatological disease
* clinical and significant skin condition on the test area (e.g. lesions, scars,malformations)
* diabetes
* endocrine disease
* hepatic, renal or cardiac disorder
* cancer
* topical drugs or surgical procedure on the test areas during the previous 3 months
* systemic corticosteroids
* aspirin or non-steroid anti-inflammatory drugs (FANS)
* diuretic drugs
* antibiotics and chemotherapics
* psychotropic drugs
* retinoids
* psoralens
* cardiologic and vascular drugs
What they're measuring
1
Erythema evaluation (MED-optical densitometry)
Timeframe: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment), T12 and T16 (follow-up visits - 12 and 16 weeks after T0)