<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/NCT01732497</url>
  </required_header>
  <id_info>
    <org_study_id>CP-0009</org_study_id>
    <nct_id>NCT01732497</nct_id>
  </id_info>
  <brief_title>A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System</brief_title>
  <official_title>A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miramar Labs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Miramar Labs</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate hair reduction in the underarms in patients treated&#xD;
      with the miraDry System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to quantify the amount of hair reduction in patients treated with the&#xD;
      miraDry System in the axilla. Hair counts will be assessed before and after treatments&#xD;
      including at follow up visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Patients with successful hair reduction</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of patients that show a &gt;=30% reduction in underarm hair at the 3 month visit compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients with successful hair reduction</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of patients that achieve a &gt;=30% reduction in underarm hair at the 12 month visit compared to baseline</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient satisfaction with hair reduction</measure>
    <time_frame>All follow-up visits through 12 months</time_frame>
    <description>Patients will provide their evaluation of satisfaction with the hair reduction seen</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Underarm Hair</condition>
  <arm_group>
    <arm_group_label>Single Group miraDry Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a single group study where each enrolled subject will receive active miraDry treatment in each axilla.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>miraDry Treatment</intervention_name>
    <description>Application of electromagnetic energy to heat the lower dermis.</description>
    <arm_group_label>Single Group miraDry Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age&#xD;
&#xD;
          -  Visible underarm hair (prefer light colored hair; blonde, red, gray)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary Axillary Hyperhidrosis&#xD;
&#xD;
          -  Prior surgery and/or Botox Injections in axillae&#xD;
&#xD;
          -  Pacemaker or requires supplemental oxygen&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathy Quiroz, BS, RN</last_name>
    <role>Study Director</role>
    <affiliation>Miramar Labs, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zel Skin and Laser Specialists</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laser &amp; Skin Surgery Center of NY</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Dermatology</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>March 30, 2016</last_update_submitted>
  <last_update_submitted_qc>March 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Underarm Hair</keyword>
  <keyword>Underarm Hair Reduction</keyword>
  <keyword>Axillary Hair</keyword>
  <keyword>Axillary Hair Reduction</keyword>
  <keyword>Underarm Odor</keyword>
  <keyword>Axillary Odor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01732497
org study id: CP-0009
nct id: NCT01732497
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate hair reduction in the underarms in patients treated
      with the miraDry System.
This study is designed to quantify the amount of hair reduction in patients treated with the
      miraDry System in the axilla. Hair counts will be assessed before and after treatments
      including at follow up visits.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patients with successful hair reduction
time frame: 3 months
description: Percentage of patients that show a >=30% reduction in underarm hair at the 3 month visit compared to baseline.
measure: Patients with successful hair reduction
time frame: 12 months
description: Percentage of patients that achieve a >=30% reduction in underarm hair at the 12 month visit compared to baseline
measure: Patient satisfaction with hair reduction
time frame: All follow-up visits through 12 months
description: Patients will provide their evaluation of satisfaction with the hair reduction seen
arm group label: Single Group miraDry Treatment
arm group type: Experimental
description: This is a single group study where each enrolled subject will receive active miraDry treatment in each axilla.
intervention type: Device
intervention name: miraDry Treatment
description: Application of electromagnetic energy to heat the lower dermis.
arm group label: Single Group miraDry Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kathy Quiroz, BS, RN
role: Study Director
affiliation: Miramar Labs, Inc
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alopecia
sharing ipd: No