Clinical trial NCT03801343: Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement
Official title: Efficacy and Tolerance Evaluation of "Nutrakos®" Amino Acid Food Supplement (Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Photoaging
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 12
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of superficial skin hydration
timeFrame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
measure: Change from baseline of deep skin hydration
timeFrame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
measure: Change from baseline of skin plastoelasticity
timeFrame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
Secondary outcomes:
measure: Change from baseline of tolerance
timeFrame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: DERMING
state: MI
Study officials:
References: