<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/NCT02213055</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00000685</org_study_id>
    <nct_id>NCT02213055</nct_id>
  </id_info>
  <brief_title>Pediatric Head Lice Study Product Comparison</brief_title>
  <official_title>Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hackensack Meridian Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hackensack Meridian Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric&#xD;
           population.&#xD;
&#xD;
        -  To evaluate the safety of LiceMD in a pediatric population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per&#xD;
      year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common&#xD;
      perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs&#xD;
      most often by human head-to-head contact, and much less commonly by the sharing of personal&#xD;
      items such as hats, coats, combs, or towels. Because head lice feed on human blood, they&#xD;
      cannot live on pets and are only viable 1-2 days on surfaces other than the human head.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Free of Live Head Lice and Free of Viable Eggs</measure>
    <time_frame>Day after first treatment and Day 14 of study</time_frame>
    <description>A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14.&#xD;
At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Head Lice</condition>
  <arm_group>
    <arm_group_label>LICEMD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Head lice product</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LICEMD</intervention_name>
    <description>Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. Participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application.</description>
    <arm_group_label>LICEMD</arm_group_label>
    <other_name>Generic Name: Dimethicone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard Head lice product</intervention_name>
    <description>The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any examination, the school nurse will instruct the parent/guardian to retreat.</description>
    <arm_group_label>Standard Head lice product</arm_group_label>
    <other_name>permethrin (5%)</other_name>
    <other_name>malathion (0.5%)</other_name>
    <other_name>lindane (1%)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject Inclusion Criteria&#xD;
&#xD;
          -  Current lice infestation, confirmed by school nurse. Must have live lice - not just&#xD;
             eggs. A minimum of one live louse and 10 viable eggs must be seen or three live lice.&#xD;
&#xD;
          -  Male or female child; age 3 - 12&#xD;
&#xD;
          -  Willing to participate in study, and parent/guardian sign informed consent&#xD;
&#xD;
          -  Parent/guardian must be able to read and follow directions and complete all&#xD;
             questionnaires&#xD;
&#xD;
          -  For children/parents who agree to the experimental arm of the study, agree not to use&#xD;
             any other head lice product or home remedy lice treatment during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No live lice, only eggs.&#xD;
&#xD;
          -  Less than three live lice observed with less than ten viable eggs&#xD;
&#xD;
          -  No hair on the head&#xD;
&#xD;
          -  Buzz cut or crew cut&#xD;
&#xD;
          -  Use of other lice treatment or home remedy lice treatment within the past 4 weeks&#xD;
&#xD;
          -  Chronic scalp disorder (such as psoriasis) that would limit the school nurse's ability&#xD;
             to detect lice and/or identify adverse events&#xD;
&#xD;
          -  Currently taking an antibiotic&#xD;
&#xD;
          -  Does not follow instructions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lawrence Rosen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hackensack Meridian Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Boscamp, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hackensack Meridian Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>March 30, 2016</results_first_submitted>
  <results_first_submitted_qc>June 20, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 29, 2016</results_first_posted>
  <last_update_submitted>June 20, 2016</last_update_submitted>
  <last_update_submitted_qc>June 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lice Infestations</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Permethrin</mesh_term>
    <mesh_term>Malathion</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The protocol and clinical dataset will be made available upon request to any scientist wishing to use them for non-commercial purposes.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>LICEMD</title>
          <description>Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.&#xD;
LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat.</description>
        </group>
        <group group_id="P2">
          <title>Standard Head Lice Product</title>
          <description>Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.&#xD;
Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol was not Followed at Enrollment</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol was not Followed during Study</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Documentation Issue at Enrollment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Documentation Issue during Study</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not have Live Lice</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Had another Treatment during the Study</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet Inclusion Criteria</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not Return to School</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.</population>
      <group_list>
        <group group_id="B1">
          <title>LiceMD</title>
          <description>Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.&#xD;
LiceMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat.</description>
        </group>
        <group group_id="B2">
          <title>Standard Head Lice Product</title>
          <description>Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.&#xD;
Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application.</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="58"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="58"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;=18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.98" spread="1.73"/>
                    <measurement group_id="B3" value="6.98" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B3" value="13"/>
                  </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="58"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Free of Live Head Lice and Free of Viable Eggs</title>
        <description>A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14.&#xD;
At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice.</description>
        <time_frame>Day after first treatment and Day 14 of study</time_frame>
        <population>There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>LiceMD</title>
            <description>Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.&#xD;
LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat.</description>
          </group>
          <group group_id="O2">
            <title>Standard Head Lice Product</title>
            <description>Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.&#xD;
Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Free of Live Head Lice and Free of Viable Eggs</title>
          <description>A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14.&#xD;
At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice.</description>
          <population>There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 Free of live lice</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 Free of live lice</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 Free of viable eggs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 Free of viable eggs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected throughout the period during which subjects were enrolled in the study, which was four years and one month.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>LiceMD</title>
          <description>Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.&#xD;
LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat.</description>
        </group>
        <group group_id="E2">
          <title>Standard Head Lice Product</title>
          <description>Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.&#xD;
Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application.</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="97"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="1" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <description>School nurse transcribed adverse event (reported by parent/guardian), as &quot;Irritation on cheek at time of shampoo application&quot; which occurred &quot;10 min after shampoo was washed off.&quot; Irritation lasted 10 minutes and no medical attention was needed.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Project Manager, Environmental Research</name_or_title>
      <organization>The Deirdre Imus Environmental Health Center at HackensackUMC</organization>
      <phone>551-996-8071</phone>
      <email>dimuscenter@hackensackumc.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/NCT02213055
org study id: Pro00000685
nct id: NCT02213055
lead sponsor: 
has dmc: No
-  To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric
           population.

        -  To evaluate the safety of LiceMD in a pediatric population.
Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per
      year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common
      perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs
      most often by human head-to-head contact, and much less commonly by the sharing of personal
      items such as hats, coats, combs, or towels. Because head lice feed on human blood, they
      cannot live on pets and are only viable 1-2 days on surfaces other than the human head.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Free of Live Head Lice and Free of Viable Eggs
time frame: Day after first treatment and Day 14 of study
description: A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14.
At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice.
arm group label: LICEMD
arm group type: Experimental
description: Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.
arm group label: Standard Head lice product
arm group type: Active Comparator
description: Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.
intervention type: Drug
intervention name: LICEMD
description: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. Participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application.
arm group label: LICEMD
other name: Generic Name: Dimethicone
intervention type: Drug
intervention name: Standard Head lice product
description: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any examination, the school nurse will instruct the parent/guardian to retreat.
arm group label: Standard Head lice product
other name: permethrin (5%)
other name: malathion (0.5%)
other name: lindane (1%)
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: No
last name: Lawrence Rosen, MD
role: Principal Investigator
affiliation: Hackensack Meridian Health
last name: Jeffrey Boscamp, MD
role: Study Director
affiliation: Hackensack Meridian Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lice Infestations
mesh term: Permethrin
mesh term: Malathion
sharing ipd: Yes
ipd description: The protocol and clinical dataset will be made available upon request to any scientist wishing to use them for non-commercial purposes.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 