Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement

Primary end point of this study was to evaluate the moisturizing and elasticizing activity of "Nutrakos®" Amino Acid Food Supplement, both photoexposed and not photoexposed on skin areas (forearm volar and dorsal surface) by non-invasive instrumental measurements; the product will be tested for 1 month by female subjects, aged 35-70 years with skin photoaging. An additional aim of this study was to evaluate the product tolerance both by investigator and volunteers.

Inclusion criteria

• female sex,
• 35-70 years,
• skin phototype II and III according to Fitzpatrick's classification (see par. 8.2.1)
• accepting to not change their habits regarding food, physical activity, body cosmetic and cleansing products;
• accepting not to expose their body to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study;
• accepting to sign the informed consent form.

Exclusion criteria

• Pregnancy;
• lactation;
• smokers;
• alcohol or drug abusers;
• skin phototype I, IV, V and VI according to Fitzpatrick's classification
• subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
• subjects not in menopause who do not accept to perform the pregnancy test at T0 and at the end of the study (T1M);
• Body Mass Index (BMI) variation (± 1) during the study period;
• change in the normal habits regarding food, physical activity, body cosmetic and cleansing use during the month preceding the test;
• sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
• subjects whose insufficient adhesion to the study protocol is foreseeable;
• participation in a similar study currently or during the previous 6 months;
• dermatitis;
• presence of cutaneous disease on the tested area, as lesions, scars, malformations;
• clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne);
• diabetes;
• endocrine disease;
• hepatic disorder;
• renal disorder;
• cardiac disorder;
• pulmonary disease;
• cancer;
• neurological or psychological disease;
• inflammatory/immunosuppressive disease;
• drug allergy;
• anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year before the study);
• using of drugs able to influence the test results in the investigator opinion.