<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/NCT03286101</url>
  </required_header>
  <id_info>
    <org_study_id>RD2017-01</org_study_id>
    <nct_id>NCT03286101</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation in Filipinos</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Clinical Trial On The Efficacy And Safety Of Topical 0.5% Ivermectin Lotion For The Treatment Of Head Lice Infestation Among Filipino Children Age 3 Years Or Older</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United Laboratories</source>
  <oversight_info>
    <is_fda_regulated_drug>No</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>
      This is a randomized, double-blind, placebo-controlled clinical study evaluating the efficacy&#xD;
      and safety of a single application of 0.5% ivermectin lotion in Filipino subjects with head&#xD;
      lice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">November 9, 2017</completion_date>
  <primary_completion_date type="Actual">October 12, 2017</primary_completion_date>
  <phase>Phase 2</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>Proportion of participants cured of head lice infestation from their assigned product on day 2, day 8 and day 15 after the first treatment.</measure>
    <time_frame>Day 2 to day 15 after product application</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Pediculosis Capitis</condition>
  <arm_group>
    <arm_group_label>0.5% Ivermectin Lotion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.5% Ivermectin lotion</intervention_name>
    <description>The intervention is composed of a single application of the 0.5% ivermectin lotion.</description>
    <arm_group_label>0.5% Ivermectin Lotion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>The intervention is composed of a single application of the vehicle control.</description>
    <arm_group_label>Vehicle control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Index subjects must have an active lice infestation defined as: At least 3 live lice&#xD;
             (adult and/or nymphs) present on the scalp and/or hair as determined by a trained&#xD;
             evaluator; After the index subject has been enrolled, additional infested household&#xD;
             members will be enrolled.&#xD;
&#xD;
          -  Household subjects must have an active head lice infestation defined as: At least 1&#xD;
             live louse (adult and /or nymph) present on the scalp and/or hair, as determined by a&#xD;
             trained evaluator (with the exception of the male head of household who may self-&#xD;
             assess, as being lice free).&#xD;
&#xD;
          -  Subject is male or female;&#xD;
&#xD;
          -  Subject is at least 3 years old or older at the time of enrollment;&#xD;
&#xD;
          -  Subject is in good general health based on the medical history;&#xD;
&#xD;
          -  Each adult subject must have an appropriately signed Informed Consent agreement. For&#xD;
             children, parents/guardian must sign an Informed Parental Consent agreement for&#xD;
             children not old enough to do so. Children of a specified age will be administered a&#xD;
             child's assent form&#xD;
&#xD;
          -  The caregiver of a subject must be willing to allow all household members to be&#xD;
             screened for head lice. If other household members are found to have an active head&#xD;
             lice infestation, they must be willing and able to participate in the study. No more&#xD;
             than one working male per household maybe excluded from evaluation if he is assessed&#xD;
             as being lice free by himself or the caregiver and cannot come in due to his work&#xD;
             schedule. If this individual may have lice, he must come to the test facility,&#xD;
             otherwise the entire household will be excluded from study participation.&#xD;
&#xD;
          -  Subject and/or caregiver must be physically able and willing to report to the testing&#xD;
             center for the supervised application of the product.&#xD;
&#xD;
          -  Subjects agrees not to use any other form of lice treatment (commercial or&#xD;
             mechanical/manual) while participating in the study;&#xD;
&#xD;
          -  Following application and rinsing of the test product, subject agrees not to shampoo /&#xD;
             wash, or rinse their hair or scalp until the 24-hour post treatment evaluation has&#xD;
             been completed;&#xD;
&#xD;
          -  Subject agrees to not cut or chemically treat their hair while participating in the&#xD;
             study;&#xD;
&#xD;
          -  Subject agrees to follow all study instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of irritation or sensitivity to ivermectin or lotion components pediculosis or&#xD;
             hair care products;&#xD;
&#xD;
          -  Presence of visible skin / scalp conditions that are not attributable to head lice&#xD;
             infestation, such as erythema, blisters, vesicles which in the opinion of the&#xD;
             investigative personnel will interfere with safety and / or efficacy evaluations;&#xD;
&#xD;
          -  Subjects suffering from psoriasis, atopic dermatitis or other conditions, which in the&#xD;
             opinion of the investigator may compromise the objective of the study;&#xD;
&#xD;
          -  Treatment for head lice (OTC, home remedy or Rx) in the last 14 days;&#xD;
&#xD;
          -  Subjects under treatment which in the opinion of the investigator will interfere with&#xD;
             the study results;&#xD;
&#xD;
          -  Subjects who participated in a previous investigational drug study within the past 30&#xD;
             days;&#xD;
&#xD;
          -  Subjects who does not understand the requirements for the study participation and/ or&#xD;
             likely exhibit poor compliance, in the opinion of the investigator;&#xD;
&#xD;
          -  Females who are pregnant or lactating.&#xD;
&#xD;
          -  Living in a household where at least one member is pregnant, lactating, or planning a&#xD;
             pregnancy&#xD;
&#xD;
          -  Subjects with skin lesions, specifically skin breaks are excluded because of possible&#xD;
             absorption of the drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gertrude Chan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Trial Management and Testing Associates, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Trial Management and Testing Associates, Inc.</name>
      <address>
        <city>Muntinlupa</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 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/NCT03286101
org study id: RD2017-01
nct id: NCT03286101
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a randomized, double-blind, placebo-controlled clinical study evaluating the efficacy
      and safety of a single application of 0.5% ivermectin lotion in Filipino subjects with head
      lice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of participants cured of head lice infestation from their assigned product on day 2, day 8 and day 15 after the first treatment.
time frame: Day 2 to day 15 after product application
arm group label: 0.5% Ivermectin Lotion
arm group type: Experimental
arm group label: Vehicle control
arm group type: Placebo Comparator
intervention type: Drug
intervention name: 0.5% Ivermectin lotion
description: The intervention is composed of a single application of the 0.5% ivermectin lotion.
arm group label: 0.5% Ivermectin Lotion
intervention type: Drug
intervention name: Vehicle
description: The intervention is composed of a single application of the vehicle control.
arm group label: Vehicle control
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gertrude Chan, M.D.
role: Principal Investigator
affiliation: Clinical Trial Management and Testing Associates, Inc.
facility: 
country: Philippines
responsible party type: Sponsor
mesh term: Lice Infestations
mesh term: Ivermectin
sharing ipd: No