<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/NCT03257943</url>
  </required_header>
  <id_info>
    <org_study_id>IVRL 1604</org_study_id>
    <nct_id>NCT03257943</nct_id>
  </id_info>
  <brief_title>A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%</brief_title>
  <official_title>A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ivermectin Lotion, 0.5% in the Treatment of Subjects With Active Infestation With Head Lice and Their Ova</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taro Pharmaceuticals USA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taro Pharmaceuticals USA</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing&#xD;
      Ivermectin Lotion, 0.5%&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing&#xD;
      Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a&#xD;
      placebo control in the treatment of subjects with active infestation with head lice and their&#xD;
      Ova&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">August 18, 2017</completion_date>
  <primary_completion_date type="Actual">June 27, 2017</primary_completion_date>
  <phase>Phase 1</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Demonstration of Bioequivalence in proportion of index subjects who are lice free</measure>
    <time_frame>Day 15 (14 days after application of study treatment)</time_frame>
    <description>Demonstration of Bioequivalence in proportion of index subjects who are lice free</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">413</enrollment>
  <condition>Lice; Head Lice</condition>
  <arm_group>
    <arm_group_label>Ivermectin Lotion, 0.5%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One 10 minute application, under at-home use conditions</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>One 10 minute application, under at-home use conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle of the Test product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One 10 minute application, under at-home use conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin Lotion, 0.5%</intervention_name>
    <description>Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)</description>
    <arm_group_label>Ivermectin Lotion, 0.5%</arm_group_label>
    <other_name>ivermectin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SKLICE (ivermectin) Lotion, 0.5%</intervention_name>
    <description>SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)</description>
    <arm_group_label>SKLICE (ivermectin) Lotion, 0.5%</arm_group_label>
    <other_name>ivermectin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle of the Test product</intervention_name>
    <description>Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)</description>
    <arm_group_label>Vehicle of the Test product</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects 18 years of age or older must have provided IRB-approved written informed&#xD;
             consent and sign a HIPAA authorization.&#xD;
&#xD;
          -  Subjects must be willing and able to understand and comply with the requirements of&#xD;
             the protocol, including attendance at the required study visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of hypersensitivity or allergy to or any component of the&#xD;
             study product.&#xD;
&#xD;
          -  Subject with history of irritation or sensitivity to pediculicides or hair care&#xD;
             products.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catawba Research</last_name>
    <role>Study Chair</role>
    <affiliation>http://catawbaresearch.com/contact/</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taro Pharmaceuticals USA Inc.</name>
      <address>
        <city>Hawthorne</city>
        <state>New York</state>
        <zip>10532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>May 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>May 16, 2018</last_update_submitted>
  <last_update_submitted_qc>May 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2018</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03257943
org study id: IVRL 1604
nct id: NCT03257943
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing
      Ivermectin Lotion, 0.5%
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing
      Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a
      placebo control in the treatment of subjects with active infestation with head lice and their
      Ova
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Demonstration of Bioequivalence in proportion of index subjects who are lice free
time frame: Day 15 (14 days after application of study treatment)
description: Demonstration of Bioequivalence in proportion of index subjects who are lice free
arm group label: Ivermectin Lotion, 0.5%
arm group type: Experimental
description: One 10 minute application, under at-home use conditions
arm group label: SKLICE (ivermectin) Lotion, 0.5%
arm group type: Active Comparator
description: One 10 minute application, under at-home use conditions
arm group label: Vehicle of the Test product
arm group type: Placebo Comparator
description: One 10 minute application, under at-home use conditions
intervention type: Drug
intervention name: Ivermectin Lotion, 0.5%
description: Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
arm group label: Ivermectin Lotion, 0.5%
other name: ivermectin
intervention type: Drug
intervention name: SKLICE (ivermectin) Lotion, 0.5%
description: SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)
arm group label: SKLICE (ivermectin) Lotion, 0.5%
other name: ivermectin
intervention type: Drug
intervention name: Vehicle of the Test product
description: Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
arm group label: Vehicle of the Test product
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Catawba Research
role: Study Chair
affiliation: http://catawbaresearch.com/contact/
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lice Infestations
mesh term: Ivermectin
sharing ipd: No