Skin PhotoagingNCT03801343
Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement
A study testing Nutrakos® in people with Skin Photoaging, run by Derming SRL at 1 site in Italy.
Trial summary
Skin moisturizing and elasticizing efficacy of an amino acid food supplement Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Photoaging
- What is being tested?
- Nutrakos®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2018to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerance Evaluation of "Nutrakos®" Amino Acid Food Supplement (Pilot Study)
Skin moisturizing and elasticizing efficacy of an amino acid food supplement
Read the 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.
- Conditions
- Skin Photoaging
- Being tested
- Nutrakos®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Nutrakos® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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).
Measured: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
Secondary outcomes (1)
Change from baseline of tolerance
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.
Measured: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start22 Nov 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adele Sparavigna, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801343
- Sponsor's protocol ID
- E1618
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance Evaluation of "Nutrakos®" Amino Acid Food Supplement (Pilot Study)
- ClinicalTrials.gov ID
- NCT03801343
- Acronym / sponsor ID
- E1618
- Conditions
- Skin Photoaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrakos® | Experimental | Dietary Supplement: Nutrakos®12 female subjects aged 35-70, have taken during a meal, for the 1 month ,2 stick packs/die of the food supplement |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (27 listed)
- Pregnancy;
- lactation;
- smokers;
- alcohol or drug abusers;
- skin phototype I, IV, V and VI according to Fitzpatrick's classification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrakos®"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. | Dietary supplement | Nutrakos® |
Primary outcome
Change from baseline of superficial skin hydration
Time frame: 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 deep skin hydration
Time frame: 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)
Change from baseline of skin plastoelasticity
Time frame: 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).
1 secondary outcome
Change from baseline of tolerance
Time frame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrakos® in people with Skin Photoaging, run by Derming SRL at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of superficial skin hydration (time frame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.