<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/NCT03273504</url>
  </required_header>
  <id_info>
    <org_study_id>E1517</org_study_id>
    <nct_id>NCT03273504</nct_id>
  </id_info>
  <brief_title>Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo</brief_title>
  <official_title>Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derming SRL</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derming SRL</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the&#xD;
      activity on hair regrowth of a topical cosmetic product versus placebo (comparison within&#xD;
      subjects)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2017</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</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 the hair density</measure>
    <time_frame>Baseline (T0), 1 month (T1), 3 months (T3)</time_frame>
    <description>Hair density (hair number/mm2) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of the percentage of terminal hair</measure>
    <time_frame>Baseline (T0), 1 month (T1), 3 months (T3)</time_frame>
    <description>Percentage of terminal hair (terminal hair has a diameter &gt;0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of the percentage of vellus hair</measure>
    <time_frame>Baseline (T0), 1 month (T1), 3 months (T3)</time_frame>
    <description>Percentage of vellus hair (terminal hair has a diameter &lt;0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of hair regrowth speed</measure>
    <time_frame>Baseline (T0), 1 month (T1), 3 months (T3)</time_frame>
    <description>Hair regrowth speed (mm/die) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of superficial skin hydration</measure>
    <time_frame>Baseline (T0), 1 month (T1), 3 months (T3)</time_frame>
    <description>Skin electrical capacitance value is measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany).&#xD;
The measure of the skin capacitance properties is an indirect expression of its hydration level.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hypertrichosis</condition>
  <arm_group>
    <arm_group_label>Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparison within subjects of Actapil Corpo Spray versus Placebo. The study product will be applied twice a dayon the right or left leg (tibialis area) according to a randomisation list.&#xD;
The placebo product will be applied in the same way, on the controlateral leg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)</intervention_name>
    <description>The study product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the right or left leg (tibialis area) according to a randomisation list.</description>
    <arm_group_label>Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The placebo product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the controlateral leg (tibialis area) right or left leg according to a randomisation list.</description>
    <arm_group_label>Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers&#xD;
&#xD;
          -  female sex&#xD;
&#xD;
          -  with hypertrichosis&#xD;
&#xD;
          -  agreeing not to perform epilation or scrub/peeling treatment on the test area (legs)&#xD;
             during the week preceding the inclusion&#xD;
&#xD;
          -  good general state of health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  lactation&#xD;
&#xD;
          -  subjects whose insufficient adhesion to the study protocol is foreseeable&#xD;
&#xD;
          -  sensitive skin&#xD;
&#xD;
          -  oral contraceptive therapy started less than 1 year&#xD;
&#xD;
          -  presence of varicose or capillary veins of surface&#xD;
&#xD;
          -  hormonal therapies able to influence hair growth.&#xD;
&#xD;
          -  presence of cutaneous disease on the tested area, as lesions, scars, malformations.&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  endocrine disease&#xD;
&#xD;
          -  hepatic disorder&#xD;
&#xD;
          -  renal disorder&#xD;
&#xD;
          -  cardiac disorder&#xD;
&#xD;
          -  cancer.&#xD;
&#xD;
          -  farmacological topical treatment and surgery and/or medical treatment on the treated&#xD;
             side performed in the last 3 months&#xD;
&#xD;
          -  systemic corticosteroids&#xD;
&#xD;
          -  aspirin or non-steroid anti-inflammatory drugs (FANS)&#xD;
&#xD;
          -  diuretic.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DERMING</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</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>Dermatologist, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrichosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03273504
org study id: E1517
nct id: NCT03273504
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the
      activity on hair regrowth of a topical cosmetic product versus placebo (comparison within
      subjects)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline of the hair density
time frame: Baseline (T0), 1 month (T1), 3 months (T3)
description: Hair density (hair number/mm2) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
measure: Change from baseline of the percentage of terminal hair
time frame: Baseline (T0), 1 month (T1), 3 months (T3)
description: Percentage of terminal hair (terminal hair has a diameter >0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
measure: Change from baseline of the percentage of vellus hair
time frame: Baseline (T0), 1 month (T1), 3 months (T3)
description: Percentage of vellus hair (terminal hair has a diameter <0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
measure: Change from baseline of hair regrowth speed
time frame: Baseline (T0), 1 month (T1), 3 months (T3)
description: Hair regrowth speed (mm/die) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
measure: Change from baseline of superficial skin hydration
time frame: Baseline (T0), 1 month (T1), 3 months (T3)
description: Skin electrical capacitance value is measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany).
The measure of the skin capacitance properties is an indirect expression of its hydration level.
arm group label: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)
arm group type: Experimental
description: Comparison within subjects of Actapil Corpo Spray versus Placebo. The study product will be applied twice a dayon the right or left leg (tibialis area) according to a randomisation list.
The placebo product will be applied in the same way, on the controlateral leg.
intervention type: Other
intervention name: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)
description: The study product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the right or left leg (tibialis area) according to a randomisation list.
arm group label: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)
intervention type: Other
intervention name: Placebo
description: The placebo product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the controlateral leg (tibialis area) right or left leg according to a randomisation list.
arm group label: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Derming SRL
investigator full name: Adele Sparavigna
investigator title: Dermatologist, Principal Investigator
mesh term: Hypertrichosis