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/NCT06028295</url>
    </required_header>
    <id_info>
      <org_study_id>IT0003622/23</org_study_id>
      <nct_id>NCT06028295</nct_id>
    </id_info>
    <brief_title>Evaluation of the Efficacy of Two Dietary Supplements on Hair Loss and Hair Aspect</brief_title>
    <official_title>Clinical-instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-hair Loss Properties and Hair Strength 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 a Wheat&#xD;
        Polar Lipid Complex (WPLC) in oil or powder form in reducing hair loss and improving hair&#xD;
        aspect.&#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 18 and 65 years old with all hair type showing diffuse and temporary&#xD;
        hair shedding with a proportion of hair in telogen phase &gt;15%. The study foresees 84 days of&#xD;
        products intake. Evaluations of the parameters under study are performed at baseline, after&#xD;
        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>Telogen hair proportion</measure>
      <time_frame>Baseline</time_frame>
      <description>Phototrichogram</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Telogen hair proportion</measure>
      <time_frame>56 days</time_frame>
      <description>Phototrichogram</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Telogen hair proportion</measure>
      <time_frame>84 days</time_frame>
      <description>Phototrichogram</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anagen hair proportion</measure>
      <time_frame>Baseline</time_frame>
      <description>Phototrichogram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anagen hair proportion</measure>
      <time_frame>56 days</time_frame>
      <description>Phototrichogram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anagen hair proportion</measure>
      <time_frame>84 days</time_frame>
      <description>Phototrichogram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hair growth</measure>
      <time_frame>84 days</time_frame>
      <description>Hair length after shaving</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hair elasticity</measure>
      <time_frame>Baseline</time_frame>
      <description>Hair elongation using dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hair elasticity</measure>
      <time_frame>84 days</time_frame>
      <description>Hair elongation using dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hair loss</measure>
      <time_frame>Baseline</time_frame>
      <description>Pull test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hair loss</measure>
      <time_frame>56 days</time_frame>
      <description>Pull test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hair loss</measure>
      <time_frame>84 days</time_frame>
      <description>Pull test</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>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">99</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Wheat Polar Lipid Complex Oil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dietary supplement - Wheat Polar Lipid Complex (Oil)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wheat Polar Lipid Complex Powder</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dietary supplement - Wheat Polar Lipid Complex (Powder)</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>Wheat Polar Lipid Complex Oil</intervention_name>
      <description>The study foresees the intake of 2 capsules per day during 84 days</description>
      <arm_group_label>Wheat Polar Lipid Complex Oil</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Wheat Polar Lipid Complex Powder</intervention_name>
      <description>The study foresees the intake of 2 capsules per day during 84 days</description>
      <arm_group_label>Wheat Polar Lipid Complex Powder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>The study foresees the intake of 2 capsules 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 18 and 65 years old (extremes included),&#xD;
  &#xD;
            -  All hair type included,&#xD;
  &#xD;
            -  Subject showing acute hair shedding (duration less than 6 months) due to fatigue,&#xD;
               seasonal change, deficiency of vitamins and minerals, stress, change or imbalance of&#xD;
               normal daily routing, or emotional stress,&#xD;
  &#xD;
            -  Women showing a proportion of hair in telogen phase &gt; 15%,&#xD;
  &#xD;
            -  Subjects complaining brittle and thin hair,&#xD;
  &#xD;
            -  Subjects who stopped any anti hair loss treatment at least 3 months prior the study,&#xD;
  &#xD;
            -  Subjects agreeing not to take any treatment (oral or topic) able to interfere with the&#xD;
               hair growth, diameter or fall during the whole study duration,&#xD;
  &#xD;
            -  Subjects who have not been involved in any other similar study in the last 3 months,&#xD;
  &#xD;
            -  Subjects registered with health social security or health social insurance, Subjects&#xD;
               able to understand the language used in the investigation center and the information&#xD;
               given&#xD;
  &#xD;
            -  Subjects able to comply with the protocol and follow protocol's constraints and&#xD;
               specific requirements&#xD;
  &#xD;
            -  Willingness to use the same products for hair care during all the study period&#xD;
  &#xD;
            -  Willingness not to cut hair for all the study length.&#xD;
  &#xD;
            -  Subjects having signed their written Informed Consent form (ICF) for their&#xD;
               participation in the study and a photograph authorization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject does not meet the inclusion criteria,&#xD;
  &#xD;
            -  Subject is taking part or planning to participate to another clinical study in the&#xD;
               same or in another investigation centre,&#xD;
  &#xD;
            -  Subject is deprived of freedom by administrative or legal decision or under&#xD;
               guardianship,&#xD;
  &#xD;
            -  Subject is admitted in a sanitary or social facilities,&#xD;
  &#xD;
            -  Subject is planning an hospitalization during the study,&#xD;
  &#xD;
            -  Subject has participated in another clinical study with anti-hair loss product or&#xD;
               treatment within the last 3 months before the inclusion visit,&#xD;
  &#xD;
            -  Subject is breastfeeding, pregnant or not willing to take necessary precautions to&#xD;
               avoid pregnancy during the study (for the women of childbearing potential),&#xD;
  &#xD;
            -  Subject has started or changed oestrogen-progesterone contraception or hormonal&#xD;
               treatment, within the 3 months prior to the study or foreseeing it for the duration of&#xD;
               the study,&#xD;
  &#xD;
            -  Subject 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;
            -  Subject is in course of a long-treatment or intending to have one considered by the&#xD;
               Investigator liable to interfere with the study data or incompatible with the study&#xD;
               requirements,&#xD;
  &#xD;
            -  Subject having a skin/scalp 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 having personal history of cosmetic, drug, domestic products or food&#xD;
               supplements allergy,&#xD;
  &#xD;
            -  Subject having food disorders,&#xD;
  &#xD;
            -  Subject who has any other hair disorder or hair disease (female pattern hair loss, any&#xD;
               type of alopecia...),&#xD;
  &#xD;
            -  Subject having excessive and/or fluctuating hair shedding for more than 6 months,&#xD;
  &#xD;
            -  History or clinical signs of hyperandrogenemia (menstrual cycle &gt;35 days and hirsutism&#xD;
               and acne),&#xD;
  &#xD;
            -  Systemic treatment affecting the hair growth taken for more than 4 consecutive weeks&#xD;
               during the last 24 weeks before inclusion visit: retinoids, anti-mitotic, cytotoxic&#xD;
               drugs other than antineoplastic, anti-androgens (spironolactone, flutamide),&#xD;
               androgens, anti-epileptic agents, interferon alpha,&#xD;
  &#xD;
            -  Systemic or local androgenetic alopecia treatment or product, taken or applied&#xD;
               (Minoxidil, Aminexil, Finasteride, Dutasteride, cosmetic solution or capsules with&#xD;
               vitamin B, zinc, caffeine...) for more than 4 consecutive weeks during the last 24&#xD;
               weeks before the inclusion visit,&#xD;
  &#xD;
            -  Any other topical treatment applied on the scalp (non-steroidal anti-inflammatory,&#xD;
               ketoconazole...) within the last 2 weeks before the inclusion visit,&#xD;
  &#xD;
            -  No hair wash in the 48 hours before each visit,&#xD;
  &#xD;
            -  Any following hair care within the last 2 weeks before each visit: dandruff shampoo,&#xD;
               antifungal shampoo, dyeing, bleaching, perm,&#xD;
  &#xD;
            -  Any hair care product applied on the scalp between the last shampoo and the inclusion&#xD;
               visit (e.g. gel, hairspray, wax, foam...),&#xD;
  &#xD;
            -  Radiotherapy, chemotherapy at any time,&#xD;
  &#xD;
            -  Scalp surgery (hair transplants, laser) at any time.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 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>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alopecia</mesh_term>
    </condition_browse>
    <!-- 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/NCT06028295
  org study id: IT0003622/23
  nct id: NCT06028295
  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 a Wheat
        Polar Lipid Complex (WPLC) in oil or powder form in reducing hair loss and improving hair
        aspect.
  A double blind, parallel groups, placebo-controlled study is carried out on 90 healthy female
        subjects aged between 18 and 65 years old with all hair type showing diffuse and temporary
        hair shedding with a proportion of hair in telogen phase >15%. The study foresees 84 days of
        products intake. Evaluations of the parameters under study are performed at baseline, after
        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: Telogen hair proportion
  time frame: Baseline
  description: Phototrichogram
  measure: Telogen hair proportion
  time frame: 56 days
  description: Phototrichogram
  measure: Telogen hair proportion
  time frame: 84 days
  description: Phototrichogram
  measure: Anagen hair proportion
  time frame: Baseline
  description: Phototrichogram
  measure: Anagen hair proportion
  time frame: 56 days
  description: Phototrichogram
  measure: Anagen hair proportion
  time frame: 84 days
  description: Phototrichogram
  measure: Hair growth
  time frame: 84 days
  description: Hair length after shaving
  measure: Hair elasticity
  time frame: Baseline
  description: Hair elongation using dynamometer
  measure: Hair elasticity
  time frame: 84 days
  description: Hair elongation using dynamometer
  measure: Hair loss
  time frame: Baseline
  description: Pull test
  measure: Hair loss
  time frame: 56 days
  description: Pull test
  measure: Hair loss
  time frame: 84 days
  description: Pull test
  measure: Self-assessment of product efficacy
  time frame: 84 days
  description: Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
  arm group label: Wheat Polar Lipid Complex Oil
  arm group type: Experimental
  description: Dietary supplement - Wheat Polar Lipid Complex (Oil)
  arm group label: Wheat Polar Lipid Complex Powder
  arm group type: Experimental
  description: Dietary supplement - Wheat Polar Lipid Complex (Powder)
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Dietary supplement - Placebo
  intervention type: Dietary Supplement
  intervention name: Wheat Polar Lipid Complex Oil
  description: The study foresees the intake of 2 capsules per day during 84 days
  arm group label: Wheat Polar Lipid Complex Oil
  intervention type: Dietary Supplement
  intervention name: Wheat Polar Lipid Complex Powder
  description: The study foresees the intake of 2 capsules per day during 84 days
  arm group label: Wheat Polar Lipid Complex Powder
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: The study foresees the intake of 2 capsules per day during 84 days
  arm group label: Placebo
  criteria: 
  gender: Female
  minimum age: 18 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
  mesh term: Alopecia