<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/NCT03017846</url>
  </required_header>
  <id_info>
    <org_study_id>16-10-195</org_study_id>
    <nct_id>NCT03017846</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Steven R Cohen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment&#xD;
      option. Treatment is often available in private practice offices, where a prescribing&#xD;
      physician may offer a non-FDA approved treatment on an individualized basis. The situation is&#xD;
      different in many hospital and academic settings, such as our own for example, where the&#xD;
      formulary is defined through a FDA-approved indication. The absence of an indication&#xD;
      precludes its addition to many hospital formularies, thus limiting the options available to a&#xD;
      prescribing physician and denying patient access to a treatment offered in the private&#xD;
      practice setting. An indication and formulary status require controlled clinical trials on&#xD;
      the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this&#xD;
      commercially-viable cantharidin formulation has a comparable safety and efficacy profile as&#xD;
      formulations previously studied under conditions which most closely match the what has been&#xD;
      historically done in the clinic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">September 6, 2017</completion_date>
  <primary_completion_date type="Actual">September 6, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Total Lesion Clearance</measure>
    <time_frame>Assessed at each visit, until final visit on week 12</time_frame>
    <description>100% reduction in baseline lesion count</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions</measure>
    <time_frame>At study completion, up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Total Children's Dermatology Life Quality Index Score</measure>
    <time_frame>Baseline (At beginning of study, before treatment) and end of study (at study completion, week 12 or at earlier visit if all lesions have cleared)</time_frame>
    <description>Change in the Total Children's Dermatology Life Quality Index (CDLQI) given Visit 1 prior to the first treatment and at the last study visit, up to 12 weeks. The CDLQI examines how the patient feels about the symptoms and treatment, as well as how it affects leisure, school, personal relationships, sleep, clothing choices. A total score is calculated.&#xD;
The total score for the CDLQI scores range:&#xD;
0-1 = no effect on child's life 2-6 = small effect 7-12 = moderate effect 13-18 = very large effect 19-30 = extremely large effect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)</measure>
    <time_frame>At study completion, up to 12 weeks</time_frame>
    <description>Comparison of the number of subjects achieving complete lesion clearance at study completion (up to 12 weeks) to the same measure obtained in our previous study (NCT02665260)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Molluscum Contagiosum</condition>
  <arm_group>
    <arm_group_label>Cantharidin Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cantharidin</intervention_name>
    <description>Application of topical cantharidin</description>
    <arm_group_label>Cantharidin Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diagnosis of MC by the Principal Investigator.&#xD;
&#xD;
        Maximum of 50 lesions on locations including the face, trunk, back, left or right arm, left&#xD;
        or right leg, hands, feet, buttocks, and groin.&#xD;
&#xD;
        Execution of Informed Consent and or assent forms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with immunosuppression, including organ transplantation, HIV infection.&#xD;
&#xD;
        Patients utilizing immunosuppressive agents (including oral corticosteroids) will be&#xD;
        excluded except for patients using inhaled corticosteroids, such as those utilized for&#xD;
        asthma or allergic rhinitis.&#xD;
&#xD;
        Females who have reached menarche and are sexually active as well as pregnant patients will&#xD;
        be excluded as the effects of this drug have not been evaluated in pregnancy.&#xD;
&#xD;
        Patients who have greater than 50 MC lesions will also be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven R Cohen, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College of Medicine/Montefiore Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <results_first_submitted>September 6, 2018</results_first_submitted>
  <results_first_submitted_qc>January 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 30, 2019</results_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Steven R Cohen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molluscum Contagiosum</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cantharidin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03017846/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cantharidin Treatment</title>
          <description>Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.&#xD;
Cantharidin: Application of topical cantharidin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cantharidin Treatment</title>
          <description>Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.&#xD;
Cantharidin: Application of topical cantharidin</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age 1-3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 4-6 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 7-10 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 11-13 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 14-17 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Total Lesion Clearance</title>
        <description>100% reduction in baseline lesion count</description>
        <time_frame>Assessed at each visit, until final visit on week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cantharidin Treatment</title>
            <description>Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.&#xD;
Cantharidin: Application of topical cantharidin</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Total Lesion Clearance</title>
          <description>100% reduction in baseline lesion count</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions</title>
        <time_frame>At study completion, up to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cantharidin Treatment</title>
            <description>Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.&#xD;
Cantharidin: Application of topical cantharidin</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions</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="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Total Children's Dermatology Life Quality Index Score</title>
        <description>Change in the Total Children's Dermatology Life Quality Index (CDLQI) given Visit 1 prior to the first treatment and at the last study visit, up to 12 weeks. The CDLQI examines how the patient feels about the symptoms and treatment, as well as how it affects leisure, school, personal relationships, sleep, clothing choices. A total score is calculated.&#xD;
The total score for the CDLQI scores range:&#xD;
0-1 = no effect on child's life 2-6 = small effect 7-12 = moderate effect 13-18 = very large effect 19-30 = extremely large effect</description>
        <time_frame>Baseline (At beginning of study, before treatment) and end of study (at study completion, week 12 or at earlier visit if all lesions have cleared)</time_frame>
        <population>All patients who were not lost to follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Cantharidin Treatment</title>
            <description>Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.&#xD;
Cantharidin: Application of topical cantharidin</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Total Children's Dermatology Life Quality Index Score</title>
          <description>Change in the Total Children's Dermatology Life Quality Index (CDLQI) given Visit 1 prior to the first treatment and at the last study visit, up to 12 weeks. The CDLQI examines how the patient feels about the symptoms and treatment, as well as how it affects leisure, school, personal relationships, sleep, clothing choices. A total score is calculated.&#xD;
The total score for the CDLQI scores range:&#xD;
0-1 = no effect on child's life 2-6 = small effect 7-12 = moderate effect 13-18 = very large effect 19-30 = extremely large effect</description>
          <population>All patients who were not lost to follow-up.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At beginning of study, before treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At end of study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)</title>
        <description>Comparison of the number of subjects achieving complete lesion clearance at study completion (up to 12 weeks) to the same measure obtained in our previous study (NCT02665260)</description>
        <time_frame>At study completion, up to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Current Study</title>
            <description>Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks in the present study.&#xD;
Cantharidin: Application of topical cantharidin</description>
          </group>
          <group group_id="O2">
            <title>NCT02665260</title>
            <description>Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks in the previous study NCT02665260.&#xD;
Cantharidin: Application of topical cantharidin</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)</title>
          <description>Comparison of the number of subjects achieving complete lesion clearance at study completion (up to 12 weeks) to the same measure obtained in our previous study (NCT02665260)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected through study completion, up to 12 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cantharidin Treatment</title>
          <description>Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.&#xD;
Cantharidin: Application of topical cantharidin</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="28" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Tooth Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pharyngitis Streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Application Site Discoloration</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Application Site Vesicles</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dermatitis Atopic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Skin pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rash Erythematous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rash Papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Scab</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </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>Anthony Guzman, MD</name_or_title>
      <organization>Albert Einstein College of Medicine</organization>
      <phone>7189208352</phone>
      <email>anguzman@montefiore.org</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/NCT03017846
org study id: 16-10-195
nct id: NCT03017846
lead sponsor: 
has dmc: No
Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment
      option. Treatment is often available in private practice offices, where a prescribing
      physician may offer a non-FDA approved treatment on an individualized basis. The situation is
      different in many hospital and academic settings, such as our own for example, where the
      formulary is defined through a FDA-approved indication. The absence of an indication
      precludes its addition to many hospital formularies, thus limiting the options available to a
      prescribing physician and denying patient access to a treatment offered in the private
      practice setting. An indication and formulary status require controlled clinical trials on
      the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this
      commercially-viable cantharidin formulation has a comparable safety and efficacy profile as
      formulations previously studied under conditions which most closely match the what has been
      historically done in the clinic.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Total Lesion Clearance
time frame: Assessed at each visit, until final visit on week 12
description: 100% reduction in baseline lesion count
measure: Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions
time frame: At study completion, up to 12 weeks
measure: Change in the Total Children's Dermatology Life Quality Index Score
time frame: Baseline (At beginning of study, before treatment) and end of study (at study completion, week 12 or at earlier visit if all lesions have cleared)
description: Change in the Total Children's Dermatology Life Quality Index (CDLQI) given Visit 1 prior to the first treatment and at the last study visit, up to 12 weeks. The CDLQI examines how the patient feels about the symptoms and treatment, as well as how it affects leisure, school, personal relationships, sleep, clothing choices. A total score is calculated.
The total score for the CDLQI scores range:
0-1 = no effect on child's life 2-6 = small effect 7-12 = moderate effect 13-18 = very large effect 19-30 = extremely large effect
measure: Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)
time frame: At study completion, up to 12 weeks
description: Comparison of the number of subjects achieving complete lesion clearance at study completion (up to 12 weeks) to the same measure obtained in our previous study (NCT02665260)
arm group label: Cantharidin Treatment
arm group type: Experimental
description: Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
intervention type: Drug
intervention name: Cantharidin
description: Application of topical cantharidin
arm group label: Cantharidin Treatment
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Steven R Cohen, MD, MPH
role: Principal Investigator
affiliation: Albert Einstein College of Medicine/Montefiore Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Steven R Cohen
investigator title: Professor
mesh term: Molluscum Contagiosum
mesh term: Cantharidin
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 