<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/NCT02249052</url>
  </required_header>
  <id_info>
    <org_study_id>10-Lipoma II</org_study_id>
    <nct_id>NCT02249052</nct_id>
  </id_info>
  <brief_title>Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma</brief_title>
  <official_title>A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gerut, Zachary, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Advance Biofactures Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Gerut, Zachary, M.D.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether collagenase is effective in reducing the&#xD;
      surface area of a subcutaneous benign lipoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA)&#xD;
      approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is&#xD;
      like normal fat except that it is enclosed in a balloon-like structure which is made of&#xD;
      collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein&#xD;
      that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby&#xD;
      decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one&#xD;
      lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be&#xD;
      observed similarly throughout the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Percent Change From Baseline in Surface Area of the Lipoma at Six Months</measure>
    <time_frame>Baseline and 6 months post injection</time_frame>
    <description>The primary efficacy outcome is lipoma visible surface area defined as the longest dimension (&quot;length&quot;) times the longest dimension perpendicular to length (&quot;width&quot;). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Responder Analysis</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Visible Surface Area</measure>
    <time_frame>1 Month post injection</time_frame>
    <description>Visible surface area is defined as the longest dimension (&quot;length&quot;) times the longest dimension perpendicular to length (&quot;width&quot;). Visible surface area will be analyzed as the percent change from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Visible Surface Area</measure>
    <time_frame>3 month post injection</time_frame>
    <description>Visible surface area is defined as the longest dimension (&quot;length&quot;) times the longest dimension perpendicular to length (&quot;width&quot;). Visible surface area will be analyzed as the percent change from baseline.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Lipoma</condition>
  <arm_group>
    <arm_group_label>AA4500</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>single injection of 0.58 mg study drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>single injection of placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AA4500</intervention_name>
    <description>Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously</description>
    <arm_group_label>AA4500</arm_group_label>
    <other_name>XIAFLEX, Collagenase Clostridium Histolyticum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-75 years of age, of either sex or any race&#xD;
&#xD;
          -  Clinical history of at least 2 lipomas for at least one year&#xD;
&#xD;
          -  Lipomas diagnosed as benign&#xD;
&#xD;
          -  Two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart,&#xD;
             with easily definable edges&#xD;
&#xD;
          -  Each lipoma is a single mass with easily definable edges&#xD;
&#xD;
          -  Lipomas are 5 to 24 cm squared&#xD;
&#xD;
          -  Women of childbearing potential must use an acceptable method of birth control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lipomas on the head, neck, hand or foot, or female breast&#xD;
&#xD;
          -  Women who are nursing or pregnant&#xD;
&#xD;
          -  Multi-lobular lipomas&#xD;
&#xD;
          -  Subjects who have received an investigational drug within 30 days before receiving the&#xD;
             first dose of study drug in this study&#xD;
&#xD;
          -  Subjects with a known allergy to collagenase or any of the inactive ingredients in&#xD;
             XIAFLEX&#xD;
&#xD;
          -  Subjects with uncontrolled diabetes, hypertension, or thyroid disease, or any medical&#xD;
             condition that would make the subject unsuitable for enrollment&#xD;
&#xD;
          -  Subjects having prior treatment or trauma of the lipoma that could interfere with&#xD;
             study assessments&#xD;
&#xD;
          -  Subjects with a history of connective tissue diseases, rheumatological diseases&#xD;
&#xD;
          -  Subjects taking anticoagulants or planning to receive anticoagulants (except for lo&#xD;
             dose aspirin and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days&#xD;
             of injection of study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zachary E Gerut, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Private Practice</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aesthetic Center</name>
      <address>
        <city>Hewlett</city>
        <state>New York</state>
        <zip>11557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>October 19, 2016</results_first_submitted>
  <results_first_submitted_qc>October 19, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 13, 2016</results_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lipoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were screened and enrolled at two study sites in the United States.</recruitment_details>
      <pre_assignment_details>Subjects must present with 2 lipomas meeting inclusion criteria</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AA4500 and Placebo</title>
          <description>Each subject received a single injection of 1 mL containing 0.58 mg AA4500 in one lipoma and a single injection of 1 mL placebo in another lipoma&#xD;
Lipoma #1 was randomized to AA4500 or placebo with Lipoma #2 receiving the alternate intervention</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AA4500 and Placebo</title>
          <description>single injection of 0.58 mg study drug and placebo&#xD;
Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.9" spread="9.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Surface Area of the Lipoma at Six Months</title>
        <description>The primary efficacy outcome is lipoma visible surface area defined as the longest dimension (&quot;length&quot;) times the longest dimension perpendicular to length (&quot;width&quot;). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit.</description>
        <time_frame>Baseline and 6 months post injection</time_frame>
        <population>All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.</population>
        <group_list>
          <group group_id="O1">
            <title>AA4500</title>
            <description>Each subject received a single injection of 1 mL containing 0.58 mg AA4500</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each subject received a single injection of 1 mL placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Surface Area of the Lipoma at Six Months</title>
          <description>The primary efficacy outcome is lipoma visible surface area defined as the longest dimension (&quot;length&quot;) times the longest dimension perpendicular to length (&quot;width&quot;). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit.</description>
          <population>All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.</population>
          <units>percentage change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-81.277" spread="22.9"/>
                    <measurement group_id="O2" value="2.053" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-83.330</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>25.0311</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-95.394</ci_lower_limit>
            <ci_upper_limit>-71.265</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Responder Analysis</title>
        <description>The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>All 19 participants</population>
        <group_list>
          <group group_id="O1">
            <title>AA4500</title>
            <description>Each subject received a single injection of 1 mL containing 0.58 mg AA4500</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each subject received a single injection of 1 mL placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Responder Analysis</title>
          <description>The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline</description>
          <population>All 19 participants</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Sign test</method>
            <param_type>Binomial proportion</param_type>
            <param_value>.8947</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.6686</ci_lower_limit>
            <ci_upper_limit>.9870</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months</title>
        <description>Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>All study participants</population>
        <group_list>
          <group group_id="O1">
            <title>AA4500</title>
            <description>Each participants received a single injection of 1 mL containing 0.58 mg AA4500</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant received a single injection of 1 mL placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months</title>
          <description>Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo.</description>
          <population>All study participants</population>
          <units>Percent change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-64.1818" spread="28.97"/>
                    <measurement group_id="O2" value="0.156" spread="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Satisfaction</title>
        <description>Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire</description>
        <time_frame>6 months</time_frame>
        <population>1 participant did not complete the questionnaire at the final visit; therefore the analysis population was based upon 18 participants</population>
        <group_list>
          <group group_id="O1">
            <title>AA4500</title>
            <description>Each subject received a single injection of 1 mL containing 0.58 mg AA4500</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each subject received a single injection of 1 mL placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction</title>
          <description>Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire</description>
          <population>1 participant did not complete the questionnaire at the final visit; therefore the analysis population was based upon 18 participants</population>
          <units>participants satisfied</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Visible Surface Area</title>
        <description>Visible surface area is defined as the longest dimension (&quot;length&quot;) times the longest dimension perpendicular to length (&quot;width&quot;). Visible surface area will be analyzed as the percent change from baseline.</description>
        <time_frame>1 Month post injection</time_frame>
        <population>All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.</population>
        <group_list>
          <group group_id="O1">
            <title>AA4500</title>
            <description>Each subject received a single injection of 1 mL containing 0.58 mg AA4500</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each subject received a single injection of 1 mL placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Visible Surface Area</title>
          <description>Visible surface area is defined as the longest dimension (&quot;length&quot;) times the longest dimension perpendicular to length (&quot;width&quot;). Visible surface area will be analyzed as the percent change from baseline.</description>
          <population>All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.</population>
          <units>percentage change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.74" spread="35.57"/>
                    <measurement group_id="O2" value="0.174" spread="8.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Visible Surface Area</title>
        <description>Visible surface area is defined as the longest dimension (&quot;length&quot;) times the longest dimension perpendicular to length (&quot;width&quot;). Visible surface area will be analyzed as the percent change from baseline.</description>
        <time_frame>3 month post injection</time_frame>
        <population>All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.</population>
        <group_list>
          <group group_id="O1">
            <title>AA4500</title>
            <description>Each participants received a single injection of 1 mL containing 0.58 mg AA4500</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant received a single injection of 1 mL placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Visible Surface Area</title>
          <description>Visible surface area is defined as the longest dimension (&quot;length&quot;) times the longest dimension perpendicular to length (&quot;width&quot;). Visible surface area will be analyzed as the percent change from baseline.</description>
          <population>All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.</population>
          <units>percentage change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-62.51" spread="32.14"/>
                    <measurement group_id="O2" value="0.402" spread="12.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months post administration study medication</time_frame>
      <desc>Treatment emergent adverse events were collected after the date of administration of study medication through the last visit at 6 months post administration.</desc>
      <group_list>
        <group group_id="E1">
          <title>AA4500</title>
          <description>single injection of 0.58 mg study drug&#xD;
AA4500: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>single injection of placebo&#xD;
placebo: Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MeDRA</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site Bruising</sub_title>
                <description>Administration site condition</description>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="19"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <description>Administration site condition</description>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <description>Administration site condition</description>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site pruritis</sub_title>
                <description>Administration site condition</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <description>Administration site condition</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site discolouration</sub_title>
                <description>Administration site condition</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Zachary E. Gerut, Sponsor/Investigator</name_or_title>
      <organization>Dr. Zachary E. Gerut</organization>
      <phone>516 295-2100</phone>
      <email>zger@optonline.net</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02249052
org study id: 10-Lipoma II
nct id: NCT02249052
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether collagenase is effective in reducing the
      surface area of a subcutaneous benign lipoma.
This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA)
      approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is
      like normal fat except that it is enclosed in a balloon-like structure which is made of
      collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein
      that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby
      decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one
      lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be
      observed similarly throughout the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Change From Baseline in Surface Area of the Lipoma at Six Months
time frame: Baseline and 6 months post injection
description: The primary efficacy outcome is lipoma visible surface area defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit.
measure: Responder Analysis
time frame: Baseline and 6 months
description: The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline
measure: Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months
time frame: Baseline and 6 months
description: Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo.
measure: Subject Satisfaction
time frame: 6 months
description: Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire
measure: Change in Visible Surface Area
time frame: 1 Month post injection
description: Visible surface area is defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline.
measure: Change in Visible Surface Area
time frame: 3 month post injection
description: Visible surface area is defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline.
arm group label: AA4500
arm group type: Active Comparator
description: single injection of 0.58 mg study drug
arm group label: Placebo
arm group type: Placebo Comparator
description: single injection of placebo
intervention type: Drug
intervention name: AA4500
description: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously
arm group label: AA4500
other name: XIAFLEX, Collagenase Clostridium Histolyticum
intervention type: Drug
intervention name: placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zachary E Gerut, MD
role: Principal Investigator
affiliation: Private Practice
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lipoma
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 