Status:
COMPLETED
Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement
Lead Sponsor:
Derming SRL
Conditions:
Skin Photoaging
Eligibility:
FEMALE
35-70 years
Phase:
NA
Brief Summary
Skin moisturizing and elasticizing efficacy of an amino acid food supplement
Detailed Description
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 vola...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03801343
Start Date
November 22 2018
End Date
December 21 2018
Last Update
January 11 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
DERMING
Milan, MI, Italy, 20159