<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/NCT03301649</url>
  </required_header>
  <id_info>
    <org_study_id>71691702</org_study_id>
    <nct_id>NCT03301649</nct_id>
  </id_info>
  <brief_title>Clinical Endpoint Study of Ivermectin 0.5% Lotion</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Lotion 0.5% (Actavis Laboratories UT, Inc.) to SKLICE® (Ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC) in the Treatment of Human Head Lice Infestation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Actavis Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Teva Pharmaceuticals USA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Actavis Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic&#xD;
      ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug&#xD;
      Administration (FDA) Reference Listed Drug (RLD) SKLICE® (ivermectin) lotion, 0.5% (Arbor&#xD;
      Pharmaceuticals, LLC) in participants with active head lice infestation. Additionally, both&#xD;
      the test and reference (that is; the RLD) treatments were tested for superiority to a&#xD;
      placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized by household in a 3:3:1 ratio to receive generic ivermectin&#xD;
      lotion 0.5%, Sklice (ivermectin) lotion 0.5%, or vehicle lotion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2017</start_date>
  <completion_date type="Actual">March 12, 2018</completion_date>
  <primary_completion_date type="Actual">March 12, 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>Percentage of Index Participants Who Were Considered a Treatment Success: PP Population</measure>
    <time_frame>Day 15 ± 2</time_frame>
    <description>Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Index Participants Who Were Considered a Treatment Success: mITT Population</measure>
    <time_frame>Day 15 ± 2</time_frame>
    <description>Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: PP Population</measure>
    <time_frame>Day 15 ± 2</time_frame>
    <description>Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: mITT Population</measure>
    <time_frame>Day 15 ± 2</time_frame>
    <description>Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">905</enrollment>
  <condition>Head Lice</condition>
  <arm_group>
    <arm_group_label>Generic Ivermectin Lotion 0.5%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infested household participants will administer a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sklice (Ivermectin) Lotion 0.5%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infested household participants will administer a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Lotion</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Infested household participants will administer a single application of up to 117 grams (1 tube) of vehicle topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Generic Ivermectin Lotion 0.5%</intervention_name>
    <description>Topical lotion, generic formulation of the brand product.</description>
    <arm_group_label>Generic Ivermectin Lotion 0.5%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sklice® (Ivermectin) Lotion 0.5%</intervention_name>
    <description>Topical lotion, brand product.</description>
    <arm_group_label>Sklice (Ivermectin) Lotion 0.5%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle Lotion</intervention_name>
    <description>Topical lotion, placebo. Has no active ingredient.</description>
    <arm_group_label>Vehicle Lotion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed Institutional Review Board (IRB)-approved informed consent form that meets all&#xD;
             criteria of current FDA regulations. For participants who are considered minors in the&#xD;
             state the study is being conducted (&lt;18 years in most states), the parent or legal&#xD;
             guardian should sign the consent form and the child will be required to sign a&#xD;
             participant &quot;assent&quot; form, as appropriate. Participants 11-17 years of age will read&#xD;
             and sign an IRB-approved assent form and participants 6-10 years of age will provide&#xD;
             verbal assent. Participants 6 months-5 years of age will be exempt from providing&#xD;
             assent based on the child's comprehension and cognitive skills.&#xD;
&#xD;
          2. The participant and/or the participant's parent (legal guardian) is willing to apply&#xD;
             the study product as directed, comply with study instructions, and commit to all&#xD;
             follow-up visits for the duration of the study.&#xD;
&#xD;
          3. Male or non-pregnant, non-lactating female, 6 months of age or older.&#xD;
&#xD;
          4. Females of childbearing potential must not be pregnant or lactating at Visit 1 (Day -1&#xD;
             to 1) (as confirmed by a negative urine pregnancy test with a sensitivity of less than&#xD;
             50 milli-international units/milliliter [mIU/mL] or equivalent units of human&#xD;
             chorionic gonadotropin). Women of childbearing potential must agree to the use of a&#xD;
             reliable method of contraception. (for example, total abstinence, intrauterine device,&#xD;
             a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or&#xD;
             hormonal contraceptive) throughout the study. Female participants using hormonal&#xD;
             contraceptives should have been on the same product/dosing regimen for at least 28&#xD;
             days before Visit 1 (Day -1 to 1) and should not change this regimen during the study.&#xD;
             A sterile sexual partner is not considered an adequate form of birth control.&#xD;
&#xD;
          5. Index participants (that is, the youngest household member) must have an active head&#xD;
             lice infestation, defined as ≥3 live lice (that is, live adults and/or nymphs), at&#xD;
             Visit 1 (Day -1 to 1).&#xD;
&#xD;
          6. Household members participating in the study must have ≥1 live louse (that is; live&#xD;
             adults and/or nymphs) at Visit 1 (Day -1 to 1).&#xD;
&#xD;
          7. All members of the household must be present for examination. Any male head of&#xD;
             household who is unable to attend Visit 1 (Day -1 to 1) may be assessed by a second&#xD;
             member of the household as being lice free.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant, lactating or planning to become pregnant during the study&#xD;
             period.&#xD;
&#xD;
          2. Participants who do not have a known household affiliation with their household&#xD;
             members (that is, do not stay in 1 household consistently, sleeping at 1 place several&#xD;
             nights and then at another place or location). Household is defined as living in a&#xD;
             shared area or space (for example the same house or apartment unit).&#xD;
&#xD;
          3. Any infested member of the household is unable or unwilling to be treated with the&#xD;
             study product. This includes male heads of household who do not attend Visit 1 (Day -1&#xD;
             to 1) but report infestation with lice.&#xD;
&#xD;
          4. More than 3 members of the household infested with lice.&#xD;
&#xD;
          5. Presence of visible skin/scalp condition(s) or open wounds at the application site&#xD;
             that are not attributable to head lice infestation and that in the opinion of the&#xD;
             Investigator will interfere with safety and/or efficacy evaluations.&#xD;
&#xD;
          6. Presence of eczema or atopic dermatitis at the application site.&#xD;
&#xD;
          7. Use of any prescription, over-the-counter, or home remedies for the treatment of head&#xD;
             lice within 7 days before Visit 1 (Day -1 to 1).&#xD;
&#xD;
          8. Use of pediculicides within 4 weeks before Visit 1 (Day -1 to 1).&#xD;
&#xD;
          9. Use of systemic anti-parasitic agents within four weeks before Visit 1.&#xD;
&#xD;
         10. Participants with very short (shaved) hair or who are planning to shave head during&#xD;
             the study.&#xD;
&#xD;
         11. Use of any hair dye, bleaches, hair straightening, or permanent wave solution on the&#xD;
             hair within 14 days before Visit 1 (Day -1 to 1).&#xD;
&#xD;
         12. History of allergy or sensitivity to pediculicides or hair care products.&#xD;
&#xD;
         13. History of any drug hypersensitivity or intolerance that, in the opinion of the&#xD;
             Investigator, would compromise the safety of the participant or results of the study.&#xD;
&#xD;
         14. Significant history or current acute or chronic infectious disease, system disorder,&#xD;
             Netherton's Syndrome, organ disorder (for example, hepatic or renal impairment) or&#xD;
             insufficiency, immunosuppression (from medical treatment or disease), organ&#xD;
             transplant, uncontrolled diabetes, uncontrolled hypertension, current ocular&#xD;
             condition, or other medical condition that, in the Investigator's opinion, would place&#xD;
             the study participant at undue risk by participating in the study.&#xD;
&#xD;
         15. Participants or non-infested household members who would act as the primary caregiver&#xD;
             who are of intellectually competent age but unable to understand the protocol&#xD;
             requirements, instructions, and study-related restrictions, the nature, scope, and&#xD;
             possible consequences of the clinical study.&#xD;
&#xD;
         16. Receipt of any drug as part of a research study within 30 days before Visit 1 (Day -1&#xD;
             to 1).&#xD;
&#xD;
         17. The participant is a member of the investigational study staff or a member of the&#xD;
             family of the investigational study staff.&#xD;
&#xD;
         18. Previous participation in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Actavis Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 1</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM476999.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <results_first_submitted>November 1, 2019</results_first_submitted>
  <results_first_submitted_qc>December 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 20, 2019</results_first_posted>
  <last_update_submitted>December 18, 2019</last_update_submitted>
  <last_update_submitted_qc>December 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2019</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>Lice Infestations</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivermectin</mesh_term>
  </intervention_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>February 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03301649/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>January 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03301649/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 912 infested household participants were included and 911 (905 enrolled [380 index + 525 non-index] + 6 non-enrolled) were treated. Participants were randomized in 3:3:1 to generic ivermectin, Sklice (ivermectin), or vehicle lotion. 1 participant was considered randomized but not dispensed, so not included in any treatment arm.</recruitment_details>
      <pre_assignment_details>Non-enrolled infested participants: Any household member who was infested with lice and agreed to be treated with study drug but did not participate in the study.&#xD;
912 infested patients were available to participate in the study, one patient was not dispensed study product, 911 patients (905 enrolled + 6 non-enrolled) were treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Generic Ivermectin Lotion 0.5%</title>
          <description>Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
        </group>
        <group group_id="P2">
          <title>Sklice (Ivermectin) Lotion</title>
          <description>Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
        </group>
        <group group_id="P3">
          <title>Vehicle Lotion</title>
          <description>Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="399"/>
                <participants group_id="P2" count="400"/>
                <participants group_id="P3" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="399"/>
                <participants group_id="P2" count="400"/>
                <participants group_id="P3" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Modified Intent-to-treat(mITT)Population</title>
              <participants_list>
                <participants group_id="P1" count="372"/>
                <participants group_id="P2" count="380"/>
                <participants group_id="P3" count="111"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per-protocol (PP) Population</title>
              <participants_list>
                <participants group_id="P1" count="345"/>
                <participants group_id="P2" count="354"/>
                <participants group_id="P3" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="356"/>
                <participants group_id="P2" count="356"/>
                <participants group_id="P3" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="85"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Need alternate therapy due to live lice</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="81"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all participants who were randomized and received study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Generic Ivermectin Lotion 0.5%</title>
          <description>Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
        </group>
        <group group_id="B2">
          <title>Sklice (Ivermectin) Lotion</title>
          <description>Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
        </group>
        <group group_id="B3">
          <title>Vehicle Lotion</title>
          <description>Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
        </group>
        <group group_id="B4">
          <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="399"/>
            <count group_id="B2" value="400"/>
            <count group_id="B3" value="112"/>
            <count group_id="B4" value="911"/>
          </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="18.8" spread="15.4"/>
                    <measurement group_id="B2" value="16.8" spread="13.9"/>
                    <measurement group_id="B3" value="19.0" spread="14.4"/>
                    <measurement group_id="B4" value="18.2" spread="14.6"/>
                  </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="322"/>
                    <measurement group_id="B2" value="324"/>
                    <measurement group_id="B3" value="97"/>
                    <measurement group_id="B4" value="743"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="168"/>
                  </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="344"/>
                    <measurement group_id="B2" value="346"/>
                    <measurement group_id="B3" value="93"/>
                    <measurement group_id="B4" value="783"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="128"/>
                  </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 group_id="B4" 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="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="377"/>
                    <measurement group_id="B2" value="377"/>
                    <measurement group_id="B3" value="106"/>
                    <measurement group_id="B4" value="860"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="9"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of live lice</title>
          <units>live lice</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.9" spread="4.4"/>
                    <measurement group_id="B2" value="4.4" spread="3.5"/>
                    <measurement group_id="B3" value="4.5" spread="3.1"/>
                    <measurement group_id="B4" value="4.6" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Index Participants Who Were Considered a Treatment Success: PP Population</title>
        <description>Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.</description>
        <time_frame>Day 15 ± 2</time_frame>
        <population>Index participants in PP population. PP population: randomized participants who met all eligibility criteria, applied study drug, were treatment successes/failures and made the final study visit ( Day 15 ± 2), and had no significant protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>Generic Ivermectin Lotion 0.5%</title>
            <description>Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
          </group>
          <group group_id="O2">
            <title>Sklice (Ivermectin) Lotion</title>
            <description>Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Index Participants Who Were Considered a Treatment Success: PP Population</title>
          <description>Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.</description>
          <population>Index participants in PP population. PP population: randomized participants who met all eligibility criteria, applied study drug, were treatment successes/failures and made the final study visit ( Day 15 ± 2), and had no significant protocol deviations.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9"/>
                    <measurement group_id="O2" value="89.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>If the 90% confidence interval (CI) for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>1.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.9</ci_lower_limit>
            <ci_upper_limit>7.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Index Participants Who Were Considered a Treatment Success: mITT Population</title>
        <description>Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study.</description>
        <time_frame>Day 15 ± 2</time_frame>
        <population>Index participants in mITT population. mITT population included all randomized participants who met all inclusion/exclusion criteria, applied the study product as instructed, and returned for at least 1 post-baseline evaluation visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Generic Ivermectin Lotion 0.5%</title>
            <description>Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
          </group>
          <group group_id="O2">
            <title>Sklice (Ivermectin) Lotion</title>
            <description>Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle Lotion</title>
            <description>Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Index Participants Who Were Considered a Treatment Success: mITT Population</title>
          <description>Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study.</description>
          <population>Index participants in mITT population. mITT population included all randomized participants who met all inclusion/exclusion criteria, applied the study product as instructed, and returned for at least 1 post-baseline evaluation visit.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="156"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.7"/>
                    <measurement group_id="O2" value="89.7"/>
                    <measurement group_id="O3" value="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using last observation carried forward [LOCF] method).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: PP Population</title>
        <description>Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.</description>
        <time_frame>Day 15 ± 2</time_frame>
        <population>PP population: randomized participants who met all eligibility criteria, applied study drug, were treatment successes/failures and made the final study visit (Day 15 ± 2), and had no significant protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>Generic Ivermectin Lotion 0.5%</title>
            <description>Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
          </group>
          <group group_id="O2">
            <title>Sklice (Ivermectin) Lotion</title>
            <description>Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: PP Population</title>
          <description>Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.</description>
          <population>PP population: randomized participants who met all eligibility criteria, applied study drug, were treatment successes/failures and made the final study visit (Day 15 ± 2), and had no significant protocol deviations.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="345"/>
                <count group_id="O2" value="354"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.6"/>
                    <measurement group_id="O2" value="90.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>If the 90% CI for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>0.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.6</ci_lower_limit>
            <ci_upper_limit>4.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: mITT Population</title>
        <description>Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study.</description>
        <time_frame>Day 15 ± 2</time_frame>
        <population>mITT population included all randomized participants who met all inclusion/exclusion criteria, applied the study product as instructed, and returned for at least one post-baseline evaluation visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Generic Ivermectin Lotion 0.5%</title>
            <description>Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
          </group>
          <group group_id="O2">
            <title>Sklice (Ivermectin) Lotion</title>
            <description>Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle Lotion</title>
            <description>Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: mITT Population</title>
          <description>Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study.</description>
          <population>mITT population included all randomized participants who met all inclusion/exclusion criteria, applied the study product as instructed, and returned for at least one post-baseline evaluation visit.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="372"/>
                <count group_id="O2" value="380"/>
                <count group_id="O3" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.2"/>
                    <measurement group_id="O2" value="91.3"/>
                    <measurement group_id="O3" value="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Day 17</time_frame>
      <desc>Adverse events were collected from participants who were randomized and received the study drug (Safety population).</desc>
      <group_list>
        <group group_id="E1">
          <title>Generic Ivermectin Lotion 0.5%</title>
          <description>Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
        </group>
        <group group_id="E2">
          <title>Vehicle Lotion</title>
          <description>Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</description>
        </group>
        <group group_id="E3">
          <title>Sklice (Ivermectin) Lotion</title>
          <description>Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.</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="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <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="31" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Ocular discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Application site exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Application site hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Application site laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Application site paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="399"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, CE Studies</name_or_title>
      <organization>Teva Pharmaceuticals Inc. USA</organization>
      <phone>1-888-483-8279</phone>
      <email>USMedInfo@tevapharm.com</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/NCT03301649
org study id: 71691702
nct id: NCT03301649
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic
      ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug
      Administration (FDA) Reference Listed Drug (RLD) SKLICE® (ivermectin) lotion, 0.5% (Arbor
      Pharmaceuticals, LLC) in participants with active head lice infestation. Additionally, both
      the test and reference (that is; the RLD) treatments were tested for superiority to a
      placebo.
Participants will be randomized by household in a 3:3:1 ratio to receive generic ivermectin
      lotion 0.5%, Sklice (ivermectin) lotion 0.5%, or vehicle lotion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Index Participants Who Were Considered a Treatment Success: PP Population
time frame: Day 15 ± 2
description: Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.
measure: Percentage of Index Participants Who Were Considered a Treatment Success: mITT Population
time frame: Day 15 ± 2
description: Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study.
measure: Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: PP Population
time frame: Day 15 ± 2
description: Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.
measure: Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: mITT Population
time frame: Day 15 ± 2
description: Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study.
arm group label: Generic Ivermectin Lotion 0.5%
arm group type: Experimental
description: Infested household participants will administer a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed.
arm group label: Sklice (Ivermectin) Lotion 0.5%
arm group type: Active Comparator
description: Infested household participants will administer a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed.
arm group label: Vehicle Lotion
arm group type: Placebo Comparator
description: Infested household participants will administer a single application of up to 117 grams (1 tube) of vehicle topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed.
intervention type: Drug
intervention name: Generic Ivermectin Lotion 0.5%
description: Topical lotion, generic formulation of the brand product.
arm group label: Generic Ivermectin Lotion 0.5%
intervention type: Drug
intervention name: Sklice® (Ivermectin) Lotion 0.5%
description: Topical lotion, brand product.
arm group label: Sklice (Ivermectin) Lotion 0.5%
intervention type: Drug
intervention name: Vehicle Lotion
description: Topical lotion, placebo. Has no active ingredient.
arm group label: Vehicle Lotion
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director
role: Study Director
affiliation: Actavis Inc.
facility: 
country: United States
url: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM476999.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Lice Infestations
mesh term: Ivermectin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 