<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/NCT03033004</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 61499416.5.0000.5490</org_study_id>
    <nct_id>NCT03033004</nct_id>
  </id_info>
  <brief_title>Cryolipolisis for Abdomen and Flank Fat Reduction</brief_title>
  <official_title>Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Cidade de Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade Federal de Sao Carlos</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Cidade de Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment&#xD;
      groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion&#xD;
      Cryolipolysis. The region will be treated according to the individual need, in the region of&#xD;
      abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60&#xD;
      and 90 days after randomization. Blood collections will also be performed at baseline and&#xD;
      between 14 and 21 days after randomization for evaluation of lipid profile and liver&#xD;
      function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fat layer thickness changes measured by ultrasound</measure>
    <time_frame>90 days after randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fat layer thickness changes measured by ultrasound</measure>
    <time_frame>30 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat layer thickness changes measured by ultrasound</measure>
    <time_frame>60 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in skin viscoelasticity measured by a cutometer</measure>
    <time_frame>30 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in skin viscoelasticity measured by a cutometer</measure>
    <time_frame>60 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in skin viscoelasticity measured by a cutometer</measure>
    <time_frame>90 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cholesterol levels</measure>
    <time_frame>21 days after randomization</time_frame>
    <description>Cholesterol levels will be measured in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in triglyceride levels</measure>
    <time_frame>21 days after randomization</time_frame>
    <description>Triglyceride levels will be measured in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood levels of alanine aminotransferase (ALT)</measure>
    <time_frame>21 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood levels of aspartate transaminase (AST)</measure>
    <time_frame>21 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting blood glucose</measure>
    <time_frame>21 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in circumference measurements</measure>
    <time_frame>30 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in circumference measurements</measure>
    <time_frame>60 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in circumference measurements</measure>
    <time_frame>90 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight</measure>
    <time_frame>30 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight</measure>
    <time_frame>60 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight</measure>
    <time_frame>90 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3.</measure>
    <time_frame>90 days after randomization</time_frame>
    <description>1= unsatisfied; 2= indifferent; 3= satisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3.</measure>
    <time_frame>90 days after randomization</time_frame>
    <description>1 = intolerable; 2= tolerable; 3= comfortable</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Subcutaneous Fat Disorder</condition>
  <arm_group>
    <arm_group_label>Conventional Cryolipolysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive one treatment session of conventional cryolipolisys. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contrast Cryolipolysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive one treatment session of contrast cryolipolisys. Subcutaneous fat tissue will be heated for 10 minutes, cooled for 60 minutes, and heated again for 10 minutes with the cryolipolitic device. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reperfusion Cryolipolysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive one treatment session of Reperfusion Cryolipolysis. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes and heated for 10 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Cryolipolysis</intervention_name>
    <description>Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.</description>
    <arm_group_label>Conventional Cryolipolysis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contrast Cryolipolysis</intervention_name>
    <description>Treatment will consist of a heat exposure of the subcutaneous fat for 10 minutes followed by 60 minutes of cold exposure and 10 minutes of heat exposure again. Cold and heat will be provided by the Polarys device. Polarys is a commercially available cryolipolitic device.</description>
    <arm_group_label>Contrast Cryolipolysis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reperfusion Cryolipolysis</intervention_name>
    <description>Treatment will be a cold exposure of the subcutaneous fat for 60 minutes followed by 10 minutes of heat exposure using the Polarys device. Polarys is a commercially available cryolipolitic device.</description>
    <arm_group_label>Reperfusion Cryolipolysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects&#xD;
&#xD;
          -  Body mass index &gt; 29.9 Kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Vascular diseases&#xD;
&#xD;
          -  Heart diseases&#xD;
&#xD;
          -  Liposuction or other surgical procedures for body contouring&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Wounds&#xD;
&#xD;
          -  Paroxysmal cold hemoglobinuria&#xD;
&#xD;
          -  Cold urticaria&#xD;
&#xD;
          -  Significant weight changes in the past 3 months or during treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro de Estudos e Formação Avançada Ibramed.</name>
      <address>
        <city>Amparo</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>April 19, 2018</last_update_submitted>
  <last_update_submitted_qc>April 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Cidade de Sao Paulo</investigator_affiliation>
    <investigator_full_name>Richard Eloin Liebano</investigator_full_name>
    <investigator_title>PT, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lipid Metabolism Disorders</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/NCT03033004
org study id: CAAE: 61499416.5.0000.5490
nct id: NCT03033004
lead sponsor: 
collaborator: 
has dmc: No
Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment
      groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion
      Cryolipolysis. The region will be treated according to the individual need, in the region of
      abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60
      and 90 days after randomization. Blood collections will also be performed at baseline and
      between 14 and 21 days after randomization for evaluation of lipid profile and liver
      function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fat layer thickness changes measured by ultrasound
time frame: 90 days after randomization
measure: Fat layer thickness changes measured by ultrasound
time frame: 30 days after randomization
measure: Fat layer thickness changes measured by ultrasound
time frame: 60 days after randomization
measure: Changes in skin viscoelasticity measured by a cutometer
time frame: 30 days after randomization
measure: Changes in skin viscoelasticity measured by a cutometer
time frame: 60 days after randomization
measure: Changes in skin viscoelasticity measured by a cutometer
time frame: 90 days after randomization
measure: Changes in cholesterol levels
time frame: 21 days after randomization
description: Cholesterol levels will be measured in mg/dL
measure: Changes in triglyceride levels
time frame: 21 days after randomization
description: Triglyceride levels will be measured in mg/dL
measure: Changes in blood levels of alanine aminotransferase (ALT)
time frame: 21 days after randomization
measure: Changes in blood levels of aspartate transaminase (AST)
time frame: 21 days after randomization
measure: Changes in fasting blood glucose
time frame: 21 days after randomization
measure: Changes in circumference measurements
time frame: 30 days after randomization
measure: Changes in circumference measurements
time frame: 60 days after randomization
measure: Changes in circumference measurements
time frame: 90 days after randomization
measure: Changes in body weight
time frame: 30 days after randomization
measure: Changes in body weight
time frame: 60 days after randomization
measure: Changes in body weight
time frame: 90 days after randomization
measure: Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3.
time frame: 90 days after randomization
description: 1= unsatisfied; 2= indifferent; 3= satisfied
measure: Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3.
time frame: 90 days after randomization
description: 1 = intolerable; 2= tolerable; 3= comfortable
arm group label: Conventional Cryolipolysis
arm group type: Active Comparator
description: Subjects will receive one treatment session of conventional cryolipolisys. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).
arm group label: Contrast Cryolipolysis
arm group type: Active Comparator
description: Subjects will receive one treatment session of contrast cryolipolisys. Subcutaneous fat tissue will be heated for 10 minutes, cooled for 60 minutes, and heated again for 10 minutes with the cryolipolitic device. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).
arm group label: Reperfusion Cryolipolysis
arm group type: Active Comparator
description: Subjects will receive one treatment session of Reperfusion Cryolipolysis. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes and heated for 10 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).
intervention type: Device
intervention name: Conventional Cryolipolysis
description: Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.
arm group label: Conventional Cryolipolysis
intervention type: Device
intervention name: Contrast Cryolipolysis
description: Treatment will consist of a heat exposure of the subcutaneous fat for 10 minutes followed by 60 minutes of cold exposure and 10 minutes of heat exposure again. Cold and heat will be provided by the Polarys device. Polarys is a commercially available cryolipolitic device.
arm group label: Contrast Cryolipolysis
intervention type: Device
intervention name: Reperfusion Cryolipolysis
description: Treatment will be a cold exposure of the subcutaneous fat for 60 minutes followed by 10 minutes of heat exposure using the Polarys device. Polarys is a commercially available cryolipolitic device.
arm group label: Reperfusion Cryolipolysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Cidade de Sao Paulo
investigator full name: Richard Eloin Liebano
investigator title: PT, PhD
mesh term: Lipid Metabolism Disorders