<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/NCT03236168</url>
  </required_header>
  <id_info>
    <org_study_id>14257</org_study_id>
    <nct_id>NCT03236168</nct_id>
  </id_info>
  <brief_title>Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands</brief_title>
  <official_title>Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study evaluating if treatment for scabies also treats headlice in the same&#xD;
      community&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Scabies and head lice are both ubiquitous ectoparasitic infections that have been identified&#xD;
      as common public health problems in the Pacific Island Country Territories. Mass drug&#xD;
      administration using ivermectin is increasingly recognised as an effective strategy for&#xD;
      scabies treatment and control, however, its possible impact on prevalence of head lice has&#xD;
      not been evaluated. Given that oral ivermectin is an effective treatment option for&#xD;
      pediculosis capitis, we hypothesise that community treatment with ivermectin for scabies&#xD;
      would also provide benefit by reducing prevalence of head lice infestation in the community.&#xD;
      We aim to test this hypothesis with a small-scale pilot study in the Solomon Islands.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      The study would be carried out at the Atoifi Adventist Hospital campus, on the North-Eastern&#xD;
      coast of the island of Malaita. The campus houses an estimated 180 individuals and all&#xD;
      residents would be invited to participate in the study and be offered treatment.&#xD;
&#xD;
      At baseline all individuals would undergo a standardized examination to collect data on the&#xD;
      presence of scabies, impetigo and head lice. Following examination individuals would be&#xD;
      weighed and given directly observed standard treatment for scabies.&#xD;
&#xD;
      Treatment for scabies consists of one oral dose of ivermectin (200 micrograms per kilogram)&#xD;
      at day 1 and at day 8.&#xD;
&#xD;
      Individuals with contra-indications (pregnancy, breast feeding, weight under 15kg) would be&#xD;
      offered the alternative of 5% permethrin cream and malathion shampoo.&#xD;
&#xD;
      Individuals would be re-examined at 48hours (to assess immediate killing of head lice) and&#xD;
      again at 2 weeks. Final follow-up will be at 3 months to establish: 1) whether changes in&#xD;
      head lice prevalence have been sustained 2) what the impact of treatment on scabies and&#xD;
      impetigo with ivermectin is in this specific community.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Headlice</measure>
    <time_frame>2 Weeks after treatment</time_frame>
    <description>Assessed in the study population by physical examination of hair</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Headlice</measure>
    <time_frame>48hrs after treatment</time_frame>
    <description>Assessed in the study population by physical examination of hair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Headlice</measure>
    <time_frame>3 Months after treatment</time_frame>
    <description>Assessed in the study population by physical examination of hair</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Scabies</condition>
  <condition>Head Lice</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight &lt;15kg) Permethrin Cream and Malathion shampoo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin</intervention_name>
    <description>A single weight based dose of ivermectin</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Permethrin 5%</intervention_name>
    <description>Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Malathion Shampoo 0.5%</intervention_name>
    <description>Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants living in the community will be offered treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a contradindication to study medication&#xD;
&#xD;
          -  Patients unable to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Atoifi Adventist Hospital</name>
      <address>
        <city>Atoifi</city>
        <state>Malaita</state>
        <country>Solomon Islands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Solomon Islands</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>November 8, 2018</results_first_submitted>
  <results_first_submitted_qc>March 13, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 14, 2019</results_first_posted>
  <last_update_submitted>March 13, 2019</last_update_submitted>
  <last_update_submitted_qc>March 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 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>
    <mesh_term>Scabies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivermectin</mesh_term>
    <mesh_term>Permethrin</mesh_term>
    <mesh_term>Malathion</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Anonymised data may be made available alongside any future publications</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03236168/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention Arm</title>
          <description>This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight &lt;15kg) Permethrin Cream and Malathion shampoo&#xD;
Ivermectin: A single weight based dose of ivermectin&#xD;
Permethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated&#xD;
Malathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention Arm</title>
          <description>This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight &lt;15kg) Permethrin Cream and Malathion shampoo&#xD;
Ivermectin: A single weight based dose of ivermectin&#xD;
Permethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated&#xD;
Malathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="118"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;= 10 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11-20 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 21 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </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="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Solomon Islands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Headline Prevalence</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Headlice</title>
        <description>Assessed in the study population by physical examination of hair</description>
        <time_frame>2 Weeks after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Arm</title>
            <description>This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight &lt;15kg) Permethrin Cream and Malathion shampoo&#xD;
Ivermectin: A single weight based dose of ivermectin&#xD;
Permethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated&#xD;
Malathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Headlice</title>
          <description>Assessed in the study population by physical examination of hair</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Headlice</title>
        <description>Assessed in the study population by physical examination of hair</description>
        <time_frame>48hrs after treatment</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Headlice</title>
        <description>Assessed in the study population by physical examination of hair</description>
        <time_frame>3 Months after treatment</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention Arm</title>
          <description>This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight &lt;15kg) Permethrin Cream and Malathion shampoo&#xD;
Ivermectin: A single weight based dose of ivermectin&#xD;
Permethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated&#xD;
Malathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated</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="118"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Michael Marks</name_or_title>
      <organization>London School of Hygiene and Tropical Medicine</organization>
      <phone>02079272566</phone>
      <email>michael.marks@lshtm.ac.uk</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/NCT03236168
org study id: 14257
nct id: NCT03236168
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pilot study evaluating if treatment for scabies also treats headlice in the same
      community
Background:

      Scabies and head lice are both ubiquitous ectoparasitic infections that have been identified
      as common public health problems in the Pacific Island Country Territories. Mass drug
      administration using ivermectin is increasingly recognised as an effective strategy for
      scabies treatment and control, however, its possible impact on prevalence of head lice has
      not been evaluated. Given that oral ivermectin is an effective treatment option for
      pediculosis capitis, we hypothesise that community treatment with ivermectin for scabies
      would also provide benefit by reducing prevalence of head lice infestation in the community.
      We aim to test this hypothesis with a small-scale pilot study in the Solomon Islands.

      Methodology:

      The study would be carried out at the Atoifi Adventist Hospital campus, on the North-Eastern
      coast of the island of Malaita. The campus houses an estimated 180 individuals and all
      residents would be invited to participate in the study and be offered treatment.

      At baseline all individuals would undergo a standardized examination to collect data on the
      presence of scabies, impetigo and head lice. Following examination individuals would be
      weighed and given directly observed standard treatment for scabies.

      Treatment for scabies consists of one oral dose of ivermectin (200 micrograms per kilogram)
      at day 1 and at day 8.

      Individuals with contra-indications (pregnancy, breast feeding, weight under 15kg) would be
      offered the alternative of 5% permethrin cream and malathion shampoo.

      Individuals would be re-examined at 48hours (to assess immediate killing of head lice) and
      again at 2 weeks. Final follow-up will be at 3 months to establish: 1) whether changes in
      head lice prevalence have been sustained 2) what the impact of treatment on scabies and
      impetigo with ivermectin is in this specific community.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Headlice
time frame: 2 Weeks after treatment
description: Assessed in the study population by physical examination of hair
measure: Number of Participants With Headlice
time frame: 48hrs after treatment
description: Assessed in the study population by physical examination of hair
measure: Number of Participants With Headlice
time frame: 3 Months after treatment
description: Assessed in the study population by physical examination of hair
arm group label: Intervention Arm
arm group type: Other
description: This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight <15kg) Permethrin Cream and Malathion shampoo
intervention type: Drug
intervention name: Ivermectin
description: A single weight based dose of ivermectin
arm group label: Intervention Arm
intervention type: Drug
intervention name: Permethrin 5%
description: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
arm group label: Intervention Arm
intervention type: Drug
intervention name: Malathion Shampoo 0.5%
description: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Solomon Islands
responsible party type: Sponsor
mesh term: Lice Infestations
mesh term: Scabies
mesh term: Ivermectin
mesh term: Permethrin
mesh term: Malathion
sharing ipd: Undecided
ipd description: Anonymised data may be made available alongside any future publications
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 