Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement

Not Applicable

Completed

• Conditions: Skin Photoaging
• Interventions: Dietary Supplement: Nutrakos®

• Registration Number: NCT03801343
• Lead Sponsor: Derming SRL

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.

Study Timeline

• Study Start: 2018-11-22
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Status Verified: 2019-01
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-10
• Last Update Submitted: 2019-01-10
• Study First Posted: 2019-01-11
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline of superficial skin hydration	Basal visit (T0), 2 weeks (T2W), 1 month (T1M)	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.
Change from baseline of skin plastoelasticity	Basal visit (T0), 2 weeks (T2W), 1 month (T1M)	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).
Change from baseline of deep skin hydration	Basal visit (T0), 2 weeks (T2W), 1 month (T1M)	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)

Secondary Outcome Measures

Name	Time	Method
Change from baseline of tolerance	Basal visit (T0), 2 weeks (T2W), 1 month (T1M)	The food supplement tolerance was evaluated considering: any adverse event related to the study treatment, which occurred during the study; any judgement reported by the volunteers.

Trial Locations

Locations (1)

DERMING; 🇮🇹 Milano, MI, Italy