<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03801343</url>
  </required_header>
  <id_info>
    <org_study_id>E1618</org_study_id>
    <nct_id>NCT03801343</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement</brief_title>
  <official_title>Efficacy and Tolerance Evaluation of &quot;Nutrakos®&quot; Amino Acid Food Supplement (Pilot Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derming SRL</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derming SRL</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Skin moisturizing and elasticizing efficacy of an amino acid food supplement&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary end point of this study was to evaluate the moisturizing and elasticizing activity of&#xD;
      &quot;Nutrakos®&quot; Amino Acid Food Supplement, both photoexposed and not photoexposed on skin areas&#xD;
      (forearm volar and dorsal surface) by non-invasive instrumental measurements; the product&#xD;
      will be tested for 1 month by female subjects, aged 35-70 years with skin photoaging. An&#xD;
      additional aim of this study was to evaluate the product tolerance both by investigator and&#xD;
      volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2018</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of superficial skin hydration</measure>
    <time_frame>Basal visit (T0), 2 weeks (T2W), 1 month (T1M)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of deep skin hydration</measure>
    <time_frame>Basal visit (T0), 2 weeks (T2W), 1 month (T1M)</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of skin plastoelasticity</measure>
    <time_frame>Basal visit (T0), 2 weeks (T2W), 1 month (T1M)</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of tolerance</measure>
    <time_frame>Basal visit (T0), 2 weeks (T2W), 1 month (T1M)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Skin Photoaging</condition>
  <arm_group>
    <arm_group_label>Nutrakos®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 female subjects aged 35-70, have taken during a meal, for the 1 month ,2 stick packs/die of the food supplement</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutrakos®</intervention_name>
    <description>&quot;Nutrakos®&quot; 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.</description>
    <arm_group_label>Nutrakos®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female sex,&#xD;
&#xD;
          -  35-70 years,&#xD;
&#xD;
          -  skin phototype II and III according to Fitzpatrick's classification (see par. 8.2.1)&#xD;
&#xD;
          -  accepting to not change their habits regarding food, physical activity, body cosmetic&#xD;
             and cleansing products;&#xD;
&#xD;
          -  accepting not to expose their body to strong UV irradiation (UV session, or sun&#xD;
             bathes) during the entire duration of the study;&#xD;
&#xD;
          -  accepting to sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  lactation;&#xD;
&#xD;
          -  smokers;&#xD;
&#xD;
          -  alcohol or drug abusers;&#xD;
&#xD;
          -  skin phototype I, IV, V and VI according to Fitzpatrick's classification&#xD;
&#xD;
          -  subjects not in menopause who do not use adequate contraceptive precautions in order&#xD;
             to avoid pregnancies during the study;&#xD;
&#xD;
          -  subjects not in menopause who do not accept to perform the pregnancy test at T0 and at&#xD;
             the end of the study (T1M);&#xD;
&#xD;
          -  Body Mass Index (BMI) variation (± 1) during the study period;&#xD;
&#xD;
          -  change in the normal habits regarding food, physical activity, body cosmetic and&#xD;
             cleansing use during the month preceding the test;&#xD;
&#xD;
          -  sensitivity to the test product or its ingredients (to be assessed by the investigator&#xD;
             during the baseline visit);&#xD;
&#xD;
          -  subjects whose insufficient adhesion to the study protocol is foreseeable;&#xD;
&#xD;
          -  participation in a similar study currently or during the previous 6 months;&#xD;
&#xD;
          -  dermatitis;&#xD;
&#xD;
          -  presence of cutaneous disease on the tested area, as lesions, scars, malformations;&#xD;
&#xD;
          -  clinical and significant skin condition on the test area (e.g. active eczema,&#xD;
             psoriasis, severe rosacea, scleroderma, local infections and severe acne);&#xD;
&#xD;
          -  diabetes;&#xD;
&#xD;
          -  endocrine disease;&#xD;
&#xD;
          -  hepatic disorder;&#xD;
&#xD;
          -  renal disorder;&#xD;
&#xD;
          -  cardiac disorder;&#xD;
&#xD;
          -  pulmonary disease;&#xD;
&#xD;
          -  cancer;&#xD;
&#xD;
          -  neurological or psychological disease;&#xD;
&#xD;
          -  inflammatory/immunosuppressive disease;&#xD;
&#xD;
          -  drug allergy;&#xD;
&#xD;
          -  anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids,&#xD;
             narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or&#xD;
             hormonal treatment starting more than 1 year before the study);&#xD;
&#xD;
          -  using of drugs able to influence the test results in the investigator opinion.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DERMING</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20159</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Derming SRL</investigator_affiliation>
    <investigator_full_name>Adele Sparavigna</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03801343
org study id: E1618
nct id: NCT03801343
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Skin moisturizing and elasticizing efficacy of an amino acid food supplement
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline of superficial skin hydration
time frame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
description: 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.
measure: Change from baseline of deep skin hydration
time frame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
description: 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)
measure: Change from baseline of skin plastoelasticity
time frame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
description: 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).
measure: Change from baseline of tolerance
time frame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
description: 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.
arm group label: Nutrakos®
arm group type: Experimental
description: 12 female subjects aged 35-70, have taken during a meal, for the 1 month ,2 stick packs/die of the food supplement
intervention type: Dietary Supplement
intervention name: Nutrakos®
description: "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.
arm group label: Nutrakos®
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Derming SRL
investigator full name: Adele Sparavigna
investigator title: Medical Doctor