<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/NCT03284034</url>
  </required_header>
  <id_info>
    <org_study_id>STU00205070</org_study_id>
    <nct_id>NCT03284034</nct_id>
  </id_info>
  <brief_title>Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for Upper Back Fat</brief_title>
  <official_title>Comparison of the Efficacy Between Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for the Treatment of Upper Back Fat: a Prospective Randomized Controlled Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective randomized controlled study comparing the efficacy of cryolipolysis&#xD;
      versus ATX-101 (deoxycholic acid) for the treatment of upper back fat. Participants currently&#xD;
      living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be&#xD;
      considered for enrollment. The treatment sites are the right and left upper back fat areas.&#xD;
      The right and left sides of the upper back fat will be randomly assigned (1:1) to receive&#xD;
      cryolipolysis, while the contralateral side will receive ATX-101.&#xD;
&#xD;
      This study was a pilot study designed to determine feasibility of this procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2025</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>Change in fat measurements from baseline to Day 90.</measure>
    <time_frame>Baseline and Day 90</time_frame>
    <description>Subcutaneous fat measurement will be performed using an ultrasound.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Upper Back Fat</condition>
  <arm_group>
    <arm_group_label>Cyrolipolysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Deoxycholic Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CoolCurve</intervention_name>
    <description>The right and left sides of the upper back fat will be randomly assigned to receive Cryolypolysis (CoolCurve + Advantage applicator) 35 minutes session, 3 sessions 30 days apart.</description>
    <arm_group_label>Cyrolipolysis</arm_group_label>
    <other_name>CoolSculpt</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATX-101</intervention_name>
    <description>The right and left sides of the upper back fat will be randomly assigned to receive The right and left sides of the upper back fat will be randomly assigned to receive ATX-101 (deoxycholic acid) injections, 3 sessions, 30 days apart.</description>
    <arm_group_label>Deoxycholic Acid</arm_group_label>
    <other_name>Kybella</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females ≥ 18 years old&#xD;
&#xD;
          2. Subjects are in good health as judged by the investigator.&#xD;
&#xD;
          3. Subjects with mild to moderate upper back fat.&#xD;
&#xD;
          4. Subjects who are willing and have the ability to understand and provide informed&#xD;
             consent for participation in the study and are able to communicate with the&#xD;
             investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of hypertrophic scars or keloids&#xD;
&#xD;
          2. Subjects currently under treatment with an antiplatelet or anticoagulant for any&#xD;
             medical problem or patients who have coagulation disorder&#xD;
&#xD;
          3. Subjects who have a known history of cold-induced disease such as cryoglobulinemia,&#xD;
             paroxysmal cold hemoglobulinuria, cold urticaria.&#xD;
&#xD;
          4. Pregnant or breast feeding&#xD;
&#xD;
          5. Uncooperative patients or patients with neurological disorders who are incapable of&#xD;
             following directions or who are predictably unwilling to return for follow-up&#xD;
             examinations.&#xD;
&#xD;
          6. Subjects who are unable to understand the protocol or give informed consent.&#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>Murad Alam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Murad Alam</investigator_full_name>
    <investigator_title>Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deoxycholic Acid</mesh_term>
  </intervention_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/NCT03284034
org study id: STU00205070
nct id: NCT03284034
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective randomized controlled study comparing the efficacy of cryolipolysis
      versus ATX-101 (deoxycholic acid) for the treatment of upper back fat. Participants currently
      living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be
      considered for enrollment. The treatment sites are the right and left upper back fat areas.
      The right and left sides of the upper back fat will be randomly assigned (1:1) to receive
      cryolipolysis, while the contralateral side will receive ATX-101.

      This study was a pilot study designed to determine feasibility of this procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in fat measurements from baseline to Day 90.
time frame: Baseline and Day 90
description: Subcutaneous fat measurement will be performed using an ultrasound.
arm group label: Cyrolipolysis
arm group type: Active Comparator
arm group label: Deoxycholic Acid
arm group type: Experimental
intervention type: Device
intervention name: CoolCurve
description: The right and left sides of the upper back fat will be randomly assigned to receive Cryolypolysis (CoolCurve + Advantage applicator) 35 minutes session, 3 sessions 30 days apart.
arm group label: Cyrolipolysis
other name: CoolSculpt
intervention type: Drug
intervention name: ATX-101
description: The right and left sides of the upper back fat will be randomly assigned to receive The right and left sides of the upper back fat will be randomly assigned to receive ATX-101 (deoxycholic acid) injections, 3 sessions, 30 days apart.
arm group label: Deoxycholic Acid
other name: Kybella
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Murad Alam, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Murad Alam
investigator title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
mesh term: Deoxycholic Acid
sharing ipd: No