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.
To determine the antioxidant activity of the tested product the following clinical and instrumental evaluations will be performed: 1. Evaluation of experimentally induced erythema inhibition: in basal conditions, before starting the assumption of the test product/placebo, and at T4, T8, T12, T16 weeks, each volunteer wll be exposed at the level of dorsal skin to six incremental doses of UVR (ultraviolet radiations mJ/cm2 ) in order to determine the MED (minimal erythema dose of unprotected skin). 20+/-4 hours after the UV exposure clinical and instrumental (optical densitometry) evaluations of skin erythema and photographic documentation (only on 16 preselected cases) will be performed. 2. Blood samples collection for the determination of the principal antioxidants concentration (for example: lutein, carotene, lycopene and E vitamin): at T0, T4, T8 and T12 blood samples (5 ml of venous blood) will be collected on each volunteer by the Medical Staff. The samples will be sent to an external laboratory for haematologic control task. To determine the anti-age properties of the tested product the following clinical and instrumental evaluations will be performed: 1. Non Invasive, instrumental evaluation of principal skin parameters: epicutaneous pH, skin hydration (skin electrical capacitance), skin firmness (plastoelasticity), skin texture (skin surface irregularity index - FFT on skin replicas) measurements will be performed at T0 and T8 mono-laterally at level of volar forearm medium third, left or right side according to a previously defined randomization list. 2. Clinical pictures with UV flash (Wood's light): at T0 and T8, 20 preselected cases of fairy skinned volunteers (selected on the basis of clinical ananmnesis regarding photosensitivity) will be submitted to the realization of clinical pictures at the level of the face using a special UV flash, able to highlight melanin spots, even if not yet visible at the naked eye. Moreover aim of the study is also to evaluate the best dosage of the beverage (1 or 2 servings of 250 ml/a day).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks
DermIng S.r.l
Monza, MB, Italy
Erythema evaluation (MED-optical densitometry)
Time frame: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment), T12 and T16 (follow-up visits - 12 and 16 weeks after T0)
Skin evaluations (Skin texture - Hydration - Plastoelasticity - Epicutaneous pH)
Time frame: T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis
Determination on blood samples of antioxidants diet components
Time frame: T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis
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