Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement

NCT03801343 | Completed

• 1 other identifier: E1618
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Skin moisturizing and elasticizing efficacy of an amino acid food supplement

Conditions

Skin Photoaging

Outcome Measures

Primary Outcomes (3)

• Change from baseline of superficial skin hydration

  Skin electrical capacitance value was measured mono-laterally on the right or left forearm (volar and dorsal surface) with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.

  Basal visit (T0), 2 weeks (T2W), 1 month (T1M)

• Change from baseline of deep skin hydration

  Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the right or left forearm (volar and dorsal surface) with MoistureMeterD (Delfin Technologies, Kuopio - Finland)

  Basal visit (T0), 2 weeks (T2W), 1 month (T1M)

• Change from baseline of skin plastoelasticity

  Superficial and deep skin plastoelasticity were measured mono-laterally on the right or left forearm (volar and dorsal surface) with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).

  Basal visit (T0), 2 weeks (T2W), 1 month (T1M)

Secondary Outcomes (1)

• Change from baseline of tolerance

  Basal visit (T0), 2 weeks (T2W), 1 month (T1M)

Study Arms (1)

Nutrakos®

EXPERIMENTAL

12 female subjects aged 35-70, have taken during a meal, for the 1 month ,2 stick packs/die of the food supplement

Dietary Supplement: Nutrakos®

Interventions

Nutrakos® DIETARY_SUPPLEMENT

"Nutrakos®" Amino Acid Food Supplement supplies a specific mixture of amino acids that has been proven to induce synthesis of collagen and elastin, the main proteins of derma structure in fibroblasts and keratocytes.

Nutrakos®

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female sex,
• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Milan, MI, 20159, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: November 22, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

IT (1)