<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/NCT01712451</url>
  </required_header>
  <id_info>
    <org_study_id>LIPO-102-CL-11</org_study_id>
    <nct_id>NCT01712451</nct_id>
  </id_info>
  <brief_title>Dose-ranging Study</brief_title>
  <acronym>LIPO-102-CL-11</acronym>
  <official_title>Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neothetics, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neothetics, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dose ranging study&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>8 weeks treatment</time_frame>
    <description>physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in abdominal circumference</measure>
    <time_frame>Baseline to 9 weeks</time_frame>
    <description>abdominal circumference</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in global clinician scale score</measure>
    <time_frame>Baseline to 9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in global patient scale score</measure>
    <time_frame>Baseline to 9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Photonumeric scale score</measure>
    <time_frame>Baseline to 9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Reported Outcome Score</measure>
    <time_frame>Baseline to 9 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Abdominal Contour Defects</condition>
  <arm_group>
    <arm_group_label>LIPO-102, Low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LIPO-102, Mid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LIPO-102, High</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LIPO-102; Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>salmeterol xinafoate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>salmeterol xinafoate, fluticasone propionate</intervention_name>
    <description>LIPO-102</description>
    <arm_group_label>LIPO-102, High</arm_group_label>
    <arm_group_label>LIPO-102, Low</arm_group_label>
    <arm_group_label>LIPO-102, Mid</arm_group_label>
    <other_name>LIPO-102</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>LIPO-102; Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>salmeterol xinafoate</intervention_name>
    <description>Salmeterol</description>
    <arm_group_label>salmeterol xinafoate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 - 45 years of age inclusive&#xD;
&#xD;
          -  abdominal contour defect&#xD;
&#xD;
          -  BMI &lt;25 kg/msq&#xD;
&#xD;
          -  Stable diet and exercise and body weight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc)&#xD;
&#xD;
          -  Known hypersensitivity to study drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murray Maytom</last_name>
    <role>Study Director</role>
    <affiliation>Neothetics, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <disposition_first_submitted>March 5, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>March 5, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 26, 2015</disposition_first_posted>
  <last_update_submitted>March 5, 2015</last_update_submitted>
  <last_update_submitted_qc>March 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adiposity</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
    <mesh_term>Salmeterol Xinafoate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01712451
org study id: LIPO-102-CL-11
nct id: NCT01712451
lead sponsor: 
has dmc: No
Dose ranging study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety
time frame: 8 weeks treatment
description: physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
measure: Change in abdominal circumference
time frame: Baseline to 9 weeks
description: abdominal circumference
measure: Change in global clinician scale score
time frame: Baseline to 9 weeks
measure: Change in global patient scale score
time frame: Baseline to 9 weeks
measure: Change in Photonumeric scale score
time frame: Baseline to 9 weeks
measure: Change in Patient Reported Outcome Score
time frame: Baseline to 9 weeks
arm group label: LIPO-102, Low
arm group type: Experimental
arm group label: LIPO-102, Mid
arm group type: Experimental
arm group label: LIPO-102, High
arm group type: Experimental
arm group label: LIPO-102; Placebo
arm group type: Experimental
arm group label: salmeterol xinafoate
arm group type: Experimental
intervention type: Drug
intervention name: salmeterol xinafoate, fluticasone propionate
description: LIPO-102
arm group label: LIPO-102, High
arm group label: LIPO-102, Low
arm group label: LIPO-102, Mid
other name: LIPO-102
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: LIPO-102; Placebo
intervention type: Drug
intervention name: salmeterol xinafoate
description: Salmeterol
arm group label: salmeterol xinafoate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Murray Maytom
role: Study Director
affiliation: Neothetics, Inc
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fluticasone
mesh term: Xhance
mesh term: Salmeterol Xinafoate