<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/NCT03259620</url>
  </required_header>
  <id_info>
    <org_study_id>CLS006-CO-PR-002</org_study_id>
    <nct_id>NCT03259620</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maruho Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maruho Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide&#xD;
      Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital&#xD;
      cutaneous common warts (verruca vulgaris).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">November 7, 2018</completion_date>
  <primary_completion_date type="Actual">August 22, 2018</primary_completion_date>
  <phase>Phase 3</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>The Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation</measure>
    <time_frame>Week 18</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject</measure>
    <time_frame>Week 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Wart Size for Each Subject</measure>
    <time_frame>Week 18</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">491</enrollment>
  <condition>Cutaneous Common Warts</condition>
  <arm_group>
    <arm_group_label>CLS006</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Furosemide Topical Gel, 0.125%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CLS006 Vehicle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vehicle Topical Gel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CLS006</intervention_name>
    <description>Furosemide Topical Gel</description>
    <arm_group_label>CLS006</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CLS006 Vehicle</intervention_name>
    <description>Vehicle Topical Gel</description>
    <arm_group_label>CLS006 Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have 1 to 6 clearly identifiable common warts located on hands, feet,&#xD;
             limbs, and/or trunk&#xD;
&#xD;
               -  Each wart must measure 3 to 10 mm in their longest dimension (diameter) on the&#xD;
                  epidermal plane of the skin at the baseline visit,&#xD;
&#xD;
               -  Each wart must be present for at least 4 weeks at the baseline visit,&#xD;
&#xD;
               -  Plantar, facial, subungual, and other warts (e.g., flat, genital) are excluded&#xD;
                  from treatment (i.e., these wart types are excluded from treatment, however the&#xD;
                  subject is not excluded).&#xD;
&#xD;
          -  Male or female subjects 2 years of age or older&#xD;
&#xD;
          -  Females of childbearing potential who are using a highly effective form of birth&#xD;
             control or females of non-childbearing potential&#xD;
&#xD;
          -  Negative in-office urine pregnancy test at Screening and Baseline&#xD;
&#xD;
          -  Subjects free of any clinically significant dermatologic disorder in the treatment&#xD;
             area&#xD;
&#xD;
          -  Subjects free of any clinically significant systemic condition which will interfere&#xD;
             with the study assessments or increase the risk of AEs&#xD;
&#xD;
          -  Subjects willing to refrain from using other topical products in the treatment area,&#xD;
             or prohibited medications for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have used any wart treatments/therapies, prescription or&#xD;
             over-the-counter, as follows:&#xD;
&#xD;
               -  Salicylic acid, cantharidin, sinecatechins (VeregenTM), simple occlusion (e.g.,&#xD;
                  duct tape), and/or any other over-the-counter wart-removing products in the&#xD;
                  treatment area within 4 weeks of the Baseline Visit.&#xD;
&#xD;
               -  Cryotherapy (e.g., treatment with liquid nitrogen), carbon dioxide,&#xD;
                  electrodessication, laser, surgery, or other forms of mechanical destruction&#xD;
                  (e.g., emery boards, clippers, debriders, etc.) in the treatment area within 8&#xD;
                  weeks of the Baseline Visit.&#xD;
&#xD;
               -  Treatment with immunotherapy (DPCP, DNCB or other), imiquimod, 5-fluorouracil,&#xD;
                  bleomycin, podophyllin or any other wart immunotherapy or treatment (e.g.,&#xD;
                  Candida antigen) designed to stimulate immune response within 12 weeks of the&#xD;
                  Baseline Visit.&#xD;
&#xD;
          -  Female subjects who are pregnant, nursing/breastfeeding, or plan to become pregnant&#xD;
             within the study period including the follow-up period.&#xD;
&#xD;
          -  Subjects who are immunocompromised.&#xD;
&#xD;
          -  Subjects who have taken, within 30 days prior to the Baseline visit, or require&#xD;
             treatment with systemic immunosuppressive or immunomodulatory medication (including&#xD;
             oral or parenteral corticosteroids) during the course of the study.&#xD;
&#xD;
          -  Subjects who require ongoing treatment with oral or injectable furosemide.&#xD;
&#xD;
          -  Subjects who have used an investigational drug/device within 30 days of the Baseline&#xD;
             visit&#xD;
&#xD;
          -  Subjects with known sensitivities to any of the investigational product ingredients&#xD;
             including furosemide (or other sulfonamides).&#xD;
&#xD;
          -  Subjects with clinically relevant/significant abnormal laboratory results, vital&#xD;
             signs, ECG, and/or physical findings at Screening and/or Baseline&#xD;
&#xD;
          -  Subjects with a chronic medical condition or clinically significant abnormal physical&#xD;
             or laboratory finding(s) that may require the use of a prohibited&#xD;
             medication/treatment.&#xD;
&#xD;
          -  Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol&#xD;
             or drug abuse within the past year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Burke Pharmaceutical Research</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Specialists, Inc.</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Dermatology Research Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TCR Medical Corporation</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Medical Research Center, Inc.</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Care Research, Inc.</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Associates &amp; Research</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Dermatology Research, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renstar Medical Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Clinical Research - US, LLC</name>
      <address>
        <city>Sanford</city>
        <state>Florida</state>
        <zip>32771</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marietta Dermatology Clinical Research, Inc.</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dawes Fretzin Clinical Research Group, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Research</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Pharmaceutical Research, LLC</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSearch Clinical Trials</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psoriasis Treatment Center of Central New Jersey</name>
      <address>
        <city>East Windsor</city>
        <state>New Jersey</state>
        <zip>08520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Dermatology Group, P.C.</name>
      <address>
        <city>Verona</city>
        <state>New Jersey</state>
        <zip>07044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Dermatology Associates</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Specialty Dermatology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Darst Dermatology</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Specialists of Charlotte</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Dermatology And Research Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Associates of Plymouth Meeting</name>
      <address>
        <city>Plymouth Meeting</city>
        <state>Pennsylvania</state>
        <zip>19462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PEAK Research, LLC</name>
      <address>
        <city>Upper Saint Clair</city>
        <state>Pennsylvania</state>
        <zip>15241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of the Carolinas</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Clinical Trial Services, LLC</name>
      <address>
        <city>Fountain Inn</city>
        <state>South Carolina</state>
        <zip>29644</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Clinical Research - Tennessee LLC</name>
      <address>
        <city>Murfreesboro</city>
        <state>Tennessee</state>
        <zip>37130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Clinical Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arlington Research Center, Inc.</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Institute for Clinical Research, Inc</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Clinical Research Center of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research, Inc.</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <results_first_submitted>May 24, 2023</results_first_submitted>
  <results_first_submitted_qc>August 21, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 14, 2023</results_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</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>Warts</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03259620/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03259620/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects must have 1 to 6 clearly identifiable common warts located on hands, feet, limbs, and/or trunk</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>CLS006</title>
          <description>Furosemide Topical Gel applied once daily Furosemide Topical Gel, 0.125%</description>
        </group>
        <group group_id="P2">
          <title>CLS006 Vehicle</title>
          <description>Vehicle Topical Gel applied once daily Vehicle Topical Gel</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="245"/>
                <participants group_id="P2" count="246"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects Who Had 1 Wart</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
                <participants group_id="P2" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects Who Had 2 Warts</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects Who Had 3 Warts</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects Who Had 4 Warts</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects Who Had 5 Warts</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects Who Had 6 Warts</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="226"/>
                <participants group_id="P2" count="217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CLS006</title>
          <description>Furosemide Topical Gel, 0.125%</description>
        </group>
        <group group_id="B2">
          <title>CLS006 Vehicle</title>
          <description>Vehicle Topical Gel</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="245"/>
            <count group_id="B2" value="246"/>
            <count group_id="B3" value="491"/>
          </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="32.1" spread="18.80"/>
                    <measurement group_id="B2" value="30.2" spread="17.26"/>
                    <measurement group_id="B3" value="31.1" spread="18.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&gt;=2 to &lt;12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=12 to &lt;18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=18 to &lt;65</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</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="138"/>
                    <measurement group_id="B2" value="129"/>
                    <measurement group_id="B3" value="267"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="198"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="375"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="219"/>
                    <measurement group_id="B2" value="211"/>
                    <measurement group_id="B3" value="430"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation</title>
        <time_frame>Week 18</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CLS006</title>
            <description>Furosemide Topical Gel, 0.125%</description>
          </group>
          <group group_id="O2">
            <title>CLS006 Vehicle</title>
            <description>Vehicle Topical Gel</description>
          </group>
        </group_list>
        <measure>
          <title>The Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="226"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Achieved complete clearance of all treated warts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not achieved complete clearance of all treated warts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="191"/>
                    <measurement group_id="O2" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2587</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject</title>
        <time_frame>Week 18</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CLS006</title>
            <description>Furosemide Topical Gel, 0.125%</description>
          </group>
          <group group_id="O2">
            <title>CLS006 Vehicle</title>
            <description>Vehicle Topical Gel</description>
          </group>
        </group_list>
        <measure>
          <title>The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject</title>
          <units>Ratio of Cleared Warts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="226"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.210" spread="0.3771"/>
                    <measurement group_id="O2" value="0.191" spread="0.3500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12</title>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CLS006</title>
            <description>Furosemide Topical Gel, 0.125%</description>
          </group>
          <group group_id="O2">
            <title>CLS006 Vehicle</title>
            <description>Vehicle Topical Gel</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="226"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete clearance of all treated warts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not complete clearance of all treated warts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="205"/>
                    <measurement group_id="O2" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject at Week 12</title>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CLS006</title>
            <description>Furosemide Topical Gel, 0.125%</description>
          </group>
          <group group_id="O2">
            <title>CLS006 Vehicle</title>
            <description>Vehicle Topical Gel</description>
          </group>
        </group_list>
        <measure>
          <title>The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject at Week 12</title>
          <units>ratio of cleared warts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="226"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.135" spread="0.3112"/>
                    <measurement group_id="O2" value="0.127" spread="0.3020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Wart Size for Each Subject</title>
        <time_frame>Week 18</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CLS006</title>
            <description>Furosemide Topical Gel, 0.125%</description>
          </group>
          <group group_id="O2">
            <title>CLS006 Vehicle</title>
            <description>Vehicle Topical Gel</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Wart Size for Each Subject</title>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="226"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="7.10"/>
                    <measurement group_id="O2" value="-3.1" spread="6.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>18 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CLS006</title>
          <description>Furosemide Topical Gel, 0.125%</description>
        </group>
        <group group_id="E2">
          <title>CLS006 Vehicle</title>
          <description>Vehicle Topical Gel</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>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="23" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="246"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Maruho Co.,Ltd. Kyoto R&amp;D Center</name_or_title>
      <organization>Clinical Development Dept.</organization>
      <phone>+81-75-325-3255</phone>
      <email>ctinfo@mii.maruho.co.jp</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/NCT03259620
org study id: CLS006-CO-PR-002
nct id: NCT03259620
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide
      Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital
      cutaneous common warts (verruca vulgaris).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation
time frame: Week 18
measure: The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject
time frame: Week 18
measure: Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12
time frame: Week 12
measure: The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject at Week 12
time frame: Week 12
measure: Change From Baseline in Wart Size for Each Subject
time frame: Week 18
arm group label: CLS006
arm group type: Experimental
description: Furosemide Topical Gel, 0.125%
arm group label: CLS006 Vehicle
arm group type: Experimental
description: Vehicle Topical Gel
intervention type: Drug
intervention name: CLS006
description: Furosemide Topical Gel
arm group label: CLS006
intervention type: Drug
intervention name: CLS006 Vehicle
description: Vehicle Topical Gel
arm group label: CLS006 Vehicle
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Warts
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 