<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/NCT01686841</url>
  </required_header>
  <id_info>
    <org_study_id>ZA12-003</org_study_id>
    <nct_id>NCT01686841</nct_id>
  </id_info>
  <brief_title>A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production</brief_title>
  <official_title>PILOT STUDY OF NON-INVASIVE FAT LAYER REDUCTION IN THE FLANKS OF ASIAN PATIENTS WITH THE COOLCURVE+ APPLICATOR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zeltiq Aesthetics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zeltiq Aesthetics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ&#xD;
      System.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: Reduction of Sebum Production</measure>
    <time_frame>12 weeks post final treatment</time_frame>
    <description>• Reduction of sebum production as measured by the sebumeter at 2 weeks post-treatment. A 30% reduction of sebum production in any study cohort will be considered clinically meaningful.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: UADE</measure>
    <time_frame>12 weeks post final treatment</time_frame>
    <description>Frequency of unanticipated adverse device effects (UADEs). Acceptance criteria: zero incidence of UADEs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: AE's</measure>
    <time_frame>12 weeks post final treatment</time_frame>
    <description>• Secondary safety endpoint: frequency of device- or procedure-related adverse events, and assessment of side effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility: Reduction of Sebum Production</measure>
    <time_frame>12 weeks post final treatment</time_frame>
    <description>• Reduction of sebum production as measured by the sebumeter at 72 hours, 1 week, and 4 weeks post-treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Body Fat Disorder</condition>
  <arm_group>
    <arm_group_label>Fat Reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Zeltiq System</intervention_name>
    <description>Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.</description>
    <arm_group_label>Fat Reduction</arm_group_label>
    <other_name>Cryolipolysis</other_name>
    <other_name>Lipolysis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Male subjects &gt;18 years of age and &lt;25 years of age.&#xD;
&#xD;
          2. Subject has an average sebum output on their upper back of at least 20, as measured by&#xD;
             the sebumeter&#xD;
&#xD;
          3. Subject has Fitzpatrick Skin Phototypes I-III (see Appendix A)&#xD;
&#xD;
          4. Willingness to participate in the study&#xD;
&#xD;
          5. Willingness to receive EXPERIMENTAL treatment&#xD;
&#xD;
          6. Informed consent agreement signed by the subject&#xD;
&#xD;
          7. Willingness to follow the treatment schedule and post treatment care requirements&#xD;
&#xD;
          8. Willingness to not use topical or systemic retinoids or antibiotics during the course&#xD;
             of the treatment&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Subject has a history of isotretinoin use&#xD;
&#xD;
          2. Subject has an infection or other dermatologic condition (aside from acne) in the area&#xD;
             to be treated&#xD;
&#xD;
          3. Subject has known cold sensitivity disorders including Raynaud's phenomena, cold&#xD;
             urticaria, cryoglobulinemia, and cold induced hemoglobinuria&#xD;
&#xD;
          4. Presence of suntan in the area to be treated&#xD;
&#xD;
          5. Subject is immunosuppressed&#xD;
&#xD;
          6. Subject is unable to comply with treatment, home care or follow-up visits&#xD;
&#xD;
          7. Subject has a history of vitiligo&#xD;
&#xD;
          8. Subject has a history of keloid formation&#xD;
&#xD;
          9. Subject is currently enrolled in a clinical study of any other unapproved&#xD;
             investigational drug or device.&#xD;
&#xD;
         10. Any other condition or laboratory value that would, in the professional opinion of the&#xD;
             investigator, potentially affect the subject's response or the integrity of the data&#xD;
             or would pose an unacceptable risk to the subject.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rox Anderson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MGH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>June 20, 2017</last_update_submitted>
  <last_update_submitted_qc>June 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lipolysis</keyword>
  <keyword>Cryolipolysis</keyword>
  <keyword>Fat Reduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lipid Metabolism Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 4, 2021</submitted>
    <returned>December 2, 2021</returned>
    <submitted>December 2, 2021</submitted>
    <returned>December 30, 2021</returned>
  </pending_results>
  <!-- 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/NCT01686841
org study id: ZA12-003
nct id: NCT01686841
lead sponsor: 
has dmc: No
To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ
      System.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Feasibility: Reduction of Sebum Production
time frame: 12 weeks post final treatment
description: • Reduction of sebum production as measured by the sebumeter at 2 weeks post-treatment. A 30% reduction of sebum production in any study cohort will be considered clinically meaningful.
measure: Safety: UADE
time frame: 12 weeks post final treatment
description: Frequency of unanticipated adverse device effects (UADEs). Acceptance criteria: zero incidence of UADEs.
measure: Safety: AE's
time frame: 12 weeks post final treatment
description: • Secondary safety endpoint: frequency of device- or procedure-related adverse events, and assessment of side effects.
measure: Feasibility: Reduction of Sebum Production
time frame: 12 weeks post final treatment
description: • Reduction of sebum production as measured by the sebumeter at 72 hours, 1 week, and 4 weeks post-treatment.
arm group label: Fat Reduction
arm group type: Experimental
intervention type: Device
intervention name: The Zeltiq System
description: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
arm group label: Fat Reduction
other name: Cryolipolysis
other name: Lipolysis
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rox Anderson, MD
role: Principal Investigator
affiliation: MGH
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lipid Metabolism Disorders
sharing ipd: No
submitted: November 4, 2021
returned: December 2, 2021
submitted: December 2, 2021
returned: December 30, 2021