<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/NCT01701271</url>
  </required_header>
  <id_info>
    <org_study_id>MEXIS-HAIR LOSS-STUDY 1.2012</org_study_id>
    <nct_id>NCT01701271</nct_id>
  </id_info>
  <brief_title>Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females</brief_title>
  <acronym>MEXISPATENT</acronym>
  <official_title>Evaluation of the Efficacy of the Cosmetic Lotion M.P.A.F. (Mixture of Paraffin, Alcohol and Fur) MEXIS PATENT in the Treatment of Androgenetic Alopecia by Decreasing of Hair Loss and Strengthening and Thickening of Hair in Males and Females.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mexis George</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mexis George</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the Hair Loss Prevention Lotion named&#xD;
      MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Androgenetic Alopecia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study verifies whether the tested product has any efficacy in the treatment of&#xD;
      Androgenetic Alopecia.&#xD;
&#xD;
        -  The evaluated product (Hair Loss prevention Lotion) is called:MEXIS, MPAF, M6S PATENT.&#xD;
&#xD;
        -  20 volunteers both men and women suffering from hair loss both in parties and over the&#xD;
           entire scalp with age between 18 and 70 years have been selected for this test .&#xD;
&#xD;
        -  Samples of the product have been applied following their usual use: as they are.&#xD;
&#xD;
        -  On the selecting volunteers have been used:&#xD;
&#xD;
             1. The pull test by pulling with fingers of some hair and counting them to estimate&#xD;
                the evolution of the pathology.&#xD;
&#xD;
             2. A sebum-meter to check the presence of scales on the scalp.&#xD;
&#xD;
             3. A polarized light video-camera to check the redness of the scalp and to have a&#xD;
                picture of hair and scalp.&#xD;
&#xD;
        -  Volunteers were also asked about:&#xD;
&#xD;
        -  Fluffiness&#xD;
&#xD;
        -  Sheen&#xD;
&#xD;
        -  Itching&#xD;
&#xD;
        -  Presence of scales on scalp&#xD;
&#xD;
        -  Oily hair&#xD;
&#xD;
        -  Product's acceptability&#xD;
&#xD;
        -  The readings are taken at 0 time (basal value), after 15 days (t15), 30 days (t30), 45&#xD;
           days (t45), 45 days (t45), 60 days (t60) and 90 days (t90) by the experimenter in the&#xD;
           medical studio. Then they analyzed and reported in a graph.&#xD;
&#xD;
        -  Summarizing tables and graphs of the data were taken during experimentation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2001</start_date>
  <completion_date type="Actual">June 2001</completion_date>
  <primary_completion_date type="Actual">June 2001</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 of the Amount of Hair Loss in a Pull Test</measure>
    <time_frame>baseline and 90 days</time_frame>
    <description>Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.&#xD;
Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.</measure>
    <time_frame>baseline and 90 days</time_frame>
    <description>Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Sebum on a Sebum-meter</measure>
    <time_frame>baseline and 90 days</time_frame>
    <description>Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Androgenetic Alopecia</condition>
  <arm_group>
    <arm_group_label>Volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Allopecia in several types apply on the scalp drops of the hair loss prevention lotion</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hair loss prevention lotion</intervention_name>
    <description>For greatest problems 20 drops on the scalp per day for 3 months. For minor problems 10 drops on the scalp three times per week for 3 months.</description>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Good state of general health&#xD;
&#xD;
          -  Suffering from hair loss&#xD;
&#xD;
          -  No pharmacological treatment in progress&#xD;
&#xD;
          -  Promise not to change the usual daily routine&#xD;
&#xD;
          -  No atopy in the anamnesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Illness&#xD;
&#xD;
          -  Good state of hair&#xD;
&#xD;
          -  Pharmacological treatment in progress&#xD;
&#xD;
          -  Denial of the continuance of the usual daily routine&#xD;
&#xD;
          -  Atopy in the anamnesis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fulvio Marzatico, Monitor</last_name>
    <role>Study Chair</role>
    <affiliation>Bio Basic EuropeResearch, Development and Dermo-Cosmetoligical Documentation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>George Mexis</name>
      <address>
        <city>Athens</city>
        <zip>11253</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <results_first_submitted>September 13, 2013</results_first_submitted>
  <results_first_submitted_qc>January 20, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 17, 2016</results_first_posted>
  <last_update_submitted>January 20, 2016</last_update_submitted>
  <last_update_submitted_qc>January 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Baldness</keyword>
  <keyword>Androgenetic Alopecia</keyword>
  <keyword>Alopecia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The recruitment started on February 2001 at the University of studies of Pavia</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Volunteers Evaluated</title>
          <description>20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Volunteers</title>
          <description>20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change of the Amount of Hair Loss in a Pull Test</title>
        <description>Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.&#xD;
Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair</description>
        <time_frame>baseline and 90 days</time_frame>
        <population>Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis</population>
        <group_list>
          <group group_id="O1">
            <title>Volunteers</title>
            <description>20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion</description>
          </group>
        </group_list>
        <measure>
          <title>Change of the Amount of Hair Loss in a Pull Test</title>
          <description>Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.&#xD;
Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair</description>
          <population>Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis</population>
          <units>Fallen hair</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" lower_limit="0.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Sebum on a Sebum-meter</title>
        <description>Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.</description>
        <time_frame>baseline and 90 days</time_frame>
        <population>Good state of general health Suffering from hair loss</population>
        <group_list>
          <group group_id="O1">
            <title>Volunteers Evaluated</title>
            <description>20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Sebum on a Sebum-meter</title>
          <description>Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.</description>
          <population>Good state of general health Suffering from hair loss</population>
          <units>mg sebum/c^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="0" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.</title>
        <description>Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments</description>
        <time_frame>baseline and 90 days</time_frame>
        <population>Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis</population>
        <group_list>
          <group group_id="O1">
            <title>Volunteers</title>
            <description>20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion</description>
          </group>
        </group_list>
        <measure>
          <title>Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.</title>
          <description>Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments</description>
          <population>Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis</population>
          <units>hairs/square inch</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" lower_limit="0.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>No adverse events were assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Volunteers</title>
          <description>20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Fulvio Marzatico</name_or_title>
      <organization>Bio Basic Europe</organization>
      <phone>(39) 0382 - 506390</phone>
      <email>fulviomk@unipv.it</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01701271
org study id: MEXIS-HAIR LOSS-STUDY 1.2012
nct id: NCT01701271
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether the Hair Loss Prevention Lotion named
      MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Androgenetic Alopecia.
This study verifies whether the tested product has any efficacy in the treatment of
      Androgenetic Alopecia.

        -  The evaluated product (Hair Loss prevention Lotion) is called:MEXIS, MPAF, M6S PATENT.

        -  20 volunteers both men and women suffering from hair loss both in parties and over the
           entire scalp with age between 18 and 70 years have been selected for this test .

        -  Samples of the product have been applied following their usual use: as they are.

        -  On the selecting volunteers have been used:

             1. The pull test by pulling with fingers of some hair and counting them to estimate
                the evolution of the pathology.

             2. A sebum-meter to check the presence of scales on the scalp.

             3. A polarized light video-camera to check the redness of the scalp and to have a
                picture of hair and scalp.

        -  Volunteers were also asked about:

        -  Fluffiness

        -  Sheen

        -  Itching

        -  Presence of scales on scalp

        -  Oily hair

        -  Product's acceptability

        -  The readings are taken at 0 time (basal value), after 15 days (t15), 30 days (t30), 45
           days (t45), 45 days (t45), 60 days (t60) and 90 days (t90) by the experimenter in the
           medical studio. Then they analyzed and reported in a graph.

        -  Summarizing tables and graphs of the data were taken during experimentation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of the Amount of Hair Loss in a Pull Test
time frame: baseline and 90 days
description: Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.
Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair
measure: Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.
time frame: baseline and 90 days
description: Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments
measure: Change of Sebum on a Sebum-meter
time frame: baseline and 90 days
description: Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.
arm group label: Volunteers
arm group type: Experimental
description: 20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Allopecia in several types apply on the scalp drops of the hair loss prevention lotion
intervention type: Other
intervention name: Hair loss prevention lotion
description: For greatest problems 20 drops on the scalp per day for 3 months. For minor problems 10 drops on the scalp three times per week for 3 months.
arm group label: Volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fulvio Marzatico, Monitor
role: Study Chair
affiliation: Bio Basic EuropeResearch, Development and Dermo-Cosmetoligical Documentation
facility: 
country: Greece
responsible party type: Sponsor
mesh term: Alopecia
mesh term: Alopecia Areata
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 