xml: <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/NCT06032598</url>
    </required_header>
    <id_info>
      <org_study_id>IT0003588/23</org_study_id>
      <nct_id>NCT06032598</nct_id>
    </id_info>
    <brief_title>Evaluation of the Anti-aging Efficacy of Two Dietary Supplements</brief_title>
    <official_title>Clinical-instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties and Skin Complexion Improvement. A Double-blind, Randomized, Placebo-controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seppic</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seppic</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>
        The study is aimed to assess the efficacy of two dietary supplements composed of berry&#xD;
        extracts in reducing skin aging signs and improving skin complexion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A double blind, parallel groups, placebo-controlled study is carried out on 90 healthy female&#xD;
        subjects aged between 35 and 65 (±2) years old with phototypes from I to III, uneven skin&#xD;
        tone, visible Crow's feet wrinkles and mild-moderate skin slackness at cheek level.&#xD;
  &#xD;
        The study foresees 84 days of products intake. Evaluations of the parameters under study are&#xD;
        performed at baseline, after 28, 56 and 84 days of products consumption.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Skin profilometry</measure>
      <time_frame>Baseline</time_frame>
      <description>Primos 3D</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skin profilometry</measure>
      <time_frame>28 days</time_frame>
      <description>Primos 3D</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skin profilometry</measure>
      <time_frame>56 days</time_frame>
      <description>Primos 3D</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skin profilometry</measure>
      <time_frame>84 days</time_frame>
      <description>Primos 3D</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Skin elasticity</measure>
      <time_frame>Baseline</time_frame>
      <description>Cutometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin elasticity</measure>
      <time_frame>28 days</time_frame>
      <description>Cutometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin elasticity</measure>
      <time_frame>56 days</time_frame>
      <description>Cutometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin elasticity</measure>
      <time_frame>84 days</time_frame>
      <description>Cutometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin color</measure>
      <time_frame>Baseline</time_frame>
      <description>CIELab color space</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin color</measure>
      <time_frame>28 days</time_frame>
      <description>CIELab color space</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin color</measure>
      <time_frame>56 days</time_frame>
      <description>CIELab color space</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin color</measure>
      <time_frame>84 days</time_frame>
      <description>CIELab color space</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Crow's feet</measure>
      <time_frame>Baseline</time_frame>
      <description>Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Crow's feet</measure>
      <time_frame>28 days</time_frame>
      <description>Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Crow's feet</measure>
      <time_frame>56 days</time_frame>
      <description>Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Crow's feet</measure>
      <time_frame>84 days</time_frame>
      <description>Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin firmness</measure>
      <time_frame>Baseline</time_frame>
      <description>Clinical scoring (5 points - internal validated scale)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin firmness</measure>
      <time_frame>28 days</time_frame>
      <description>Clinical scoring (5 points - internal validated scale)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin firmness</measure>
      <time_frame>56 days</time_frame>
      <description>Clinical scoring (5 points - internal validated scale)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin firmness</measure>
      <time_frame>84 days</time_frame>
      <description>Clinical scoring (5 points - internal validated scale)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin homogeneity improvment from baseline</measure>
      <time_frame>28 days</time_frame>
      <description>Clinical scoring</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin homogeneity improvment from baseline</measure>
      <time_frame>56 days</time_frame>
      <description>Clinical scoring</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin homogeneity improvment from baseline</measure>
      <time_frame>84 days</time_frame>
      <description>Clinical scoring</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-assessment of product efficacy</measure>
      <time_frame>84 days</time_frame>
      <description>Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin antioxidant potential</measure>
      <time_frame>Baseline</time_frame>
      <description>FRAP (Ferric Reducing Antioxidant Power) assay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin antioxidant potential</measure>
      <time_frame>84 days</time_frame>
      <description>FRAP (Ferric Reducing Antioxidant Power) assay</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">99</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Berry extract 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dietary supplement - Berry extract 1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Berry extract 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dietary supplement - Berry extract 2</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Dietary supplement - Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Berry extract 1</intervention_name>
      <description>The study foresees the intake of 1 capsule per day during 84 days</description>
      <arm_group_label>Berry extract 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Berry extract 2</intervention_name>
      <description>The study foresees the intake of 1 capsule per day during 84 days</description>
      <arm_group_label>Berry extract 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>The study foresees the intake of 1 capsule per day during 84 days</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria :&#xD;
  &#xD;
            -  Healthy female subjects,&#xD;
  &#xD;
            -  Caucasian ethnicity,&#xD;
  &#xD;
            -  Age between 35 and 65 (limits of ±2 years old could be included)&#xD;
  &#xD;
            -  Phototypes from I to III&#xD;
  &#xD;
            -  Subject with uneven skin tone (grade 1-3 - internal clinical scale)&#xD;
  &#xD;
            -  Subject with visible Crow's feet wrinkles (≥2 according to Skin Aging Atlas -&#xD;
               Caucasian and Asian Type - Bazin Roland)&#xD;
  &#xD;
            -  Subject with mild-moderate skin slackness at cheek level (grade 1-3 - internal&#xD;
               clinical scale).&#xD;
  &#xD;
            -  Willingness to not assume during the study period products other than the test product&#xD;
  &#xD;
            -  Subjects registered with National Health Service (NHS)&#xD;
  &#xD;
            -  Subjects certifying the truthfulness of the personal data disclosed to the&#xD;
               investigator&#xD;
  &#xD;
            -  Subjects able to understand the language used in the investigation centre and the&#xD;
               information given by the investigator&#xD;
  &#xD;
            -  Subjects able to respect the instructions given by the investigator as well as able to&#xD;
               respect the study constraints and specific requirements&#xD;
  &#xD;
            -  The pharmacological therapy (except for the pharmacological therapy in the&#xD;
               non-inclusion criteria) should be stable for at least one month without any changes&#xD;
               expected or planned during the study&#xD;
  &#xD;
            -  Commitment not to change the daily routine or the lifestyle&#xD;
  &#xD;
            -  Subjects who have not been recently involved in any other similar study (at least one&#xD;
               month of wash-out)&#xD;
  &#xD;
            -  Subject under effective contraception (oral/not oral) therapy&#xD;
  &#xD;
            -  Subjects who accept not to expose in intensive way to UV rays during the whole study&#xD;
               duration.&#xD;
  &#xD;
            -  Subject aware of the study procedures and having signed an informed consent form and&#xD;
               privacy information form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject does not meet the inclusion criteria,&#xD;
  &#xD;
            -  Subjects with acute or chronic diseases able to interfere with the outcome of the&#xD;
               study or that are considered dangerous for the subject or incompatible with the study&#xD;
               requirements&#xD;
  &#xD;
            -  Subjects participating or planning to participate in other clinical trials&#xD;
  &#xD;
            -  Subjects deprived of freedom by administrative or legal decision or under guardianship&#xD;
  &#xD;
            -  Subjects not able to be contacted in case of emergency&#xD;
  &#xD;
            -  Subjects admitted to a health or social facility&#xD;
  &#xD;
            -  Subjects planning a hospitalisation during the study&#xD;
  &#xD;
            -  Subjects who participated in a similar study without respecting an adequate washout&#xD;
               period&#xD;
  &#xD;
            -  Subjects having an acute, chronic or progressive illness liable to interfere with the&#xD;
               study data or considered by the Investigator hazardous for the subject or incompatible&#xD;
               with the study requirements&#xD;
  &#xD;
            -  Subjects under pharmacological treatments that are considered incompatible with the&#xD;
               study requirement by the investigator&#xD;
  &#xD;
            -  Subjects having a skin disease or condition liable to interfere with the study data or&#xD;
               considered by the Investigator hazardous for the subject or incompatible with the&#xD;
               study requirements&#xD;
  &#xD;
            -  Subject with known or suspected sensitization to one or more test formulation&#xD;
               ingredients&#xD;
  &#xD;
            -  Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid&#xD;
               pregnancy during the study (for the women of childbearing potential)&#xD;
  &#xD;
            -  Consumption of food supplement(s) and/or use of topical skincare products with&#xD;
               whitening activity currently or within the past 4 weeks before the study&#xD;
  &#xD;
            -  Subjects accustomed to use tanning beds&#xD;
  &#xD;
            -  Subjects taking medication with photosensitizing potential, drugs and/or dietary&#xD;
               supplements able to induce skin coloring, corticoids, currently or during the month&#xD;
               before the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ileana De Ponti</last_name>
      <role>Study Director</role>
      <affiliation>Complife Italia S.r.l</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stéphanie Dudonné</last_name>
      <phone>+ 33 563726744</phone>
      <email>stephanie.dudonne@airliquide.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Complife Italia srl</name>
        <address>
          <city>Milano</city>
          <zip>20024</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032598
  org study id: IT0003588/23
  nct id: NCT06032598
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is aimed to assess the efficacy of two dietary supplements composed of berry
        extracts in reducing skin aging signs and improving skin complexion.
  A double blind, parallel groups, placebo-controlled study is carried out on 90 healthy female
        subjects aged between 35 and 65 (±2) years old with phototypes from I to III, uneven skin
        tone, visible Crow's feet wrinkles and mild-moderate skin slackness at cheek level.
  
        The study foresees 84 days of products intake. Evaluations of the parameters under study are
        performed at baseline, after 28, 56 and 84 days of products consumption.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Skin profilometry
  time frame: Baseline
  description: Primos 3D
  measure: Skin profilometry
  time frame: 28 days
  description: Primos 3D
  measure: Skin profilometry
  time frame: 56 days
  description: Primos 3D
  measure: Skin profilometry
  time frame: 84 days
  description: Primos 3D
  measure: Skin elasticity
  time frame: Baseline
  description: Cutometer
  measure: Skin elasticity
  time frame: 28 days
  description: Cutometer
  measure: Skin elasticity
  time frame: 56 days
  description: Cutometer
  measure: Skin elasticity
  time frame: 84 days
  description: Cutometer
  measure: Skin color
  time frame: Baseline
  description: CIELab color space
  measure: Skin color
  time frame: 28 days
  description: CIELab color space
  measure: Skin color
  time frame: 56 days
  description: CIELab color space
  measure: Skin color
  time frame: 84 days
  description: CIELab color space
  measure: Crow's feet
  time frame: Baseline
  description: Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
  measure: Crow's feet
  time frame: 28 days
  description: Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
  measure: Crow's feet
  time frame: 56 days
  description: Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
  measure: Crow's feet
  time frame: 84 days
  description: Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
  measure: Skin firmness
  time frame: Baseline
  description: Clinical scoring (5 points - internal validated scale)
  measure: Skin firmness
  time frame: 28 days
  description: Clinical scoring (5 points - internal validated scale)
  measure: Skin firmness
  time frame: 56 days
  description: Clinical scoring (5 points - internal validated scale)
  measure: Skin firmness
  time frame: 84 days
  description: Clinical scoring (5 points - internal validated scale)
  measure: Skin homogeneity improvment from baseline
  time frame: 28 days
  description: Clinical scoring
  measure: Skin homogeneity improvment from baseline
  time frame: 56 days
  description: Clinical scoring
  measure: Skin homogeneity improvment from baseline
  time frame: 84 days
  description: Clinical scoring
  measure: Self-assessment of product efficacy
  time frame: 84 days
  description: Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
  measure: Skin antioxidant potential
  time frame: Baseline
  description: FRAP (Ferric Reducing Antioxidant Power) assay
  measure: Skin antioxidant potential
  time frame: 84 days
  description: FRAP (Ferric Reducing Antioxidant Power) assay
  arm group label: Berry extract 1
  arm group type: Experimental
  description: Dietary supplement - Berry extract 1
  arm group label: Berry extract 2
  arm group type: Experimental
  description: Dietary supplement - Berry extract 2
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Dietary supplement - Placebo
  intervention type: Dietary Supplement
  intervention name: Berry extract 1
  description: The study foresees the intake of 1 capsule per day during 84 days
  arm group label: Berry extract 1
  intervention type: Dietary Supplement
  intervention name: Berry extract 2
  description: The study foresees the intake of 1 capsule per day during 84 days
  arm group label: Berry extract 2
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: The study foresees the intake of 1 capsule per day during 84 days
  arm group label: Placebo
  criteria: 
  gender: Female
  minimum age: 35 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ileana De Ponti
  role: Study Director
  affiliation: Complife Italia S.r.l
  last name: Stéphanie Dudonné
  phone: + 33 563726744
  email: stephanie.dudonne@airliquide.com
  facility: 
  country: Italy
  responsible party type: Sponsor