<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/NCT02974088</url>
  </required_header>
  <id_info>
    <org_study_id>CTNC01</org_study_id>
    <nct_id>NCT02974088</nct_id>
  </id_info>
  <brief_title>Neem Lotion With Combing for Lice</brief_title>
  <official_title>A Randomised, Assessor Blinded &quot;Proof of Concept&quot; (Phase IIa) Clinical Study to Assess the Efficacy and Safety of Nice 'n Clear Head Lice Lotion in the Treatment of Head Lice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Entomology Centre</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leeds Health Protection Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PN Lee Statistics and Computing Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nelsons</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical Entomology Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a Phase IIa randomised, assessor blinded, parallel group study in which half the&#xD;
      participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with&#xD;
      a head louse detection and removal comb and the remainder were treated with Nice 'n Clear&#xD;
      plus combing with a normal grooming comb&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neem oil has had a long reputation for killing a wide range of insects, including head lice.&#xD;
      Several products are marketed with this oil as a named active ingredient, e.g. Nice 'n Clear&#xD;
      neem-based conditioning lotion. This product was developed as an aid to combing out head lice&#xD;
      for eliminating infestation but it has been considered possible that the neem oil could act&#xD;
      to kill lice and inhibit their eggs from hatching.&#xD;
&#xD;
      This study was designed to compare use of Nice 'n Clear neem-based conditioning lotion when&#xD;
      used with two different types of comb. One arm of the study was planned so that participants&#xD;
      were combed using a plastic louse detection and removal comb (wet combing with conditioner&#xD;
      method), in which it was expected the combing process would play a major role in efficacy.&#xD;
      The other arm was planned so that participants were combed using a regular grooming comb,&#xD;
      which would normally have little effect for removing head lice from the hair.&#xD;
&#xD;
      Comparison of the efficacy outcome in the two groups would determine whether the Nice 'n&#xD;
      Clear neem-based conditioning lotion exhibited any effect to eliminate infestation&#xD;
      independent of the combing&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2006</start_date>
  <completion_date type="Actual">August 2006</completion_date>
  <primary_completion_date type="Actual">August 2006</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing</measure>
    <time_frame>15 days</time_frame>
    <description>Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used</measure>
    <time_frame>15 days</time_frame>
    <description>It was expected that the louse comb group would show a high level of success (elimination of infestation). The measure of efficacy of the neem-based lotion was the relative efficacy observed in the grooming comb group compared with the louse comb group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</measure>
    <time_frame>15 days</time_frame>
    <description>Number of participants with application site reactions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Pediculoses</condition>
  <condition>Head Lice</condition>
  <arm_group>
    <arm_group_label>Neem-based lotion plus louse comb</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neem-based conditioning lotion plus head louse detection and removal comb</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neem-based lotion plus grooming comb</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neem-based conditioning lotion plus regular grooming comb</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neem-based lotion plus louse comb</intervention_name>
    <description>Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb</description>
    <arm_group_label>Neem-based lotion plus louse comb</arm_group_label>
    <other_name>Nice 'n Clear</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neem-based lotion plus grooming comb</intervention_name>
    <description>Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb</description>
    <arm_group_label>Neem-based lotion plus grooming comb</arm_group_label>
    <other_name>Nice 'n Clear</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females who are found to have an active head louse infection, i.e. the&#xD;
             presence of live lice. Detection combing will be done with a fine-toothed plastic&#xD;
             detection comb, until at least one louse is found.&#xD;
&#xD;
          -  People who give written informed consent and/or, if the participant is below 16 years&#xD;
             of age, whose guardian gives written informed consent to participate in the study.&#xD;
             Assent/verbal assent forms will be required for those between the ages of 4 and 16&#xD;
             years of age. There is no maximum age limit.&#xD;
&#xD;
          -  Participants must be available for the duration of the study i.e. 15 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People who have been treated with other head louse products within the previous 2&#xD;
             weeks (14 days).&#xD;
&#xD;
          -  People who have undergone a course of antibiotic treatment using Cotrimoxazole,&#xD;
             Trimethoprim or Septrin within the previous 4 weeks, or who are currently taking such&#xD;
             a course.&#xD;
&#xD;
          -  People whose hair has been bleached, colour treated, or semi-permanently waved within&#xD;
             the previous 2 weeks, this includes the use of semi-permanent colouring agents. Home&#xD;
             use wash in/wash out colouring agents are acceptable.&#xD;
&#xD;
          -  People who have taken part in another clinical study within 4 weeks prior to entry to&#xD;
             this one.&#xD;
&#xD;
          -  Females who are pregnant or breast-feeding.&#xD;
&#xD;
          -  Participants who have already taken part in this study.&#xD;
&#xD;
          -  People who have a known allergy to any of the ingredients of Nice 'n Clear Lotion&#xD;
             (including allergy to Paraben preservatives)&#xD;
&#xD;
          -  Children under 6 months of age.&#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>Ian F Burgess</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Entomology Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Entomology Centre</name>
      <address>
        <city>Cambridge</city>
        <zip>CB25 9AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://cordis.europa.eu/result/rcn/46970_en.html</url>
    <description>Final Report Summary - ClearBrush (A Novel Integrated Ultrasonic Brush and Sonically Activated Lotion to Provide a Full System Approach to the Eradication of the European Head Louse Menace)</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <results_first_submitted>November 16, 2018</results_first_submitted>
  <results_first_submitted_qc>November 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 14, 2019</results_first_posted>
  <last_update_submitted>November 16, 2018</last_update_submitted>
  <last_update_submitted_qc>November 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical Entomology Centre</investigator_affiliation>
    <investigator_full_name>Ian F Burgess</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lice Infestations</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Contact Principal Investigator</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment between 26 May 2006 and 31 August 2006. Community recruitment with domiciliary visits</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Neem-based Lotion Plus Louse Comb</title>
          <description>Neem-based conditioning lotion plus head louse detection and removal comb&#xD;
Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb</description>
        </group>
        <group group_id="P2">
          <title>Neem-based Lotion Plus Grooming Comb</title>
          <description>Neem-based conditioning lotion plus regular grooming comb&#xD;
Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="21">Nurse left without notice and took CRFs and data for 2 subjects.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Neem-based Lotion Plus Louse Comb</title>
          <description>Neem-based conditioning lotion plus head louse detection and removal comb&#xD;
Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb</description>
        </group>
        <group group_id="B2">
          <title>Neem-based Lotion Plus Grooming Comb</title>
          <description>Neem-based conditioning lotion plus regular grooming comb&#xD;
Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="47"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" 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>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing</title>
        <description>Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10</description>
        <time_frame>15 days</time_frame>
        <population>All participants who completed the 15 study days</population>
        <group_list>
          <group group_id="O1">
            <title>Neem-based Lotion Plus Louse Comb</title>
            <description>Neem-based conditioning lotion plus head louse detection and removal comb&#xD;
Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb</description>
          </group>
          <group group_id="O2">
            <title>Neem-based Lotion Plus Grooming Comb</title>
            <description>Neem-based conditioning lotion plus regular grooming comb&#xD;
Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing</title>
          <description>Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10</description>
          <population>All participants who completed the 15 study days</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used</title>
        <description>It was expected that the louse comb group would show a high level of success (elimination of infestation). The measure of efficacy of the neem-based lotion was the relative efficacy observed in the grooming comb group compared with the louse comb group</description>
        <time_frame>15 days</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</title>
        <description>Number of participants with application site reactions</description>
        <time_frame>15 days</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>15 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Neem-based Lotion Plus Louse Comb</title>
          <description>Neem-based conditioning lotion plus head louse detection and removal comb&#xD;
Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb</description>
        </group>
        <group group_id="E2">
          <title>Neem-based Lotion Plus Grooming Comb</title>
          <description>Neem-based conditioning lotion plus regular grooming comb&#xD;
Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb</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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Application site reaction</sub_title>
                <description>Rash</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </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>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>Ian Burgess</name_or_title>
      <organization>Medical Entomology Centre</organization>
      <phone>+44 1223 810070</phone>
      <email>ian@insectresearch.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/NCT02974088
org study id: CTNC01
nct id: NCT02974088
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This was a Phase IIa randomised, assessor blinded, parallel group study in which half the
      participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with
      a head louse detection and removal comb and the remainder were treated with Nice 'n Clear
      plus combing with a normal grooming comb
Neem oil has had a long reputation for killing a wide range of insects, including head lice.
      Several products are marketed with this oil as a named active ingredient, e.g. Nice 'n Clear
      neem-based conditioning lotion. This product was developed as an aid to combing out head lice
      for eliminating infestation but it has been considered possible that the neem oil could act
      to kill lice and inhibit their eggs from hatching.

      This study was designed to compare use of Nice 'n Clear neem-based conditioning lotion when
      used with two different types of comb. One arm of the study was planned so that participants
      were combed using a plastic louse detection and removal comb (wet combing with conditioner
      method), in which it was expected the combing process would play a major role in efficacy.
      The other arm was planned so that participants were combed using a regular grooming comb,
      which would normally have little effect for removing head lice from the hair.

      Comparison of the efficacy outcome in the two groups would determine whether the Nice 'n
      Clear neem-based conditioning lotion exhibited any effect to eliminate infestation
      independent of the combing
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing
time frame: 15 days
description: Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10
measure: Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used
time frame: 15 days
description: It was expected that the louse comb group would show a high level of success (elimination of infestation). The measure of efficacy of the neem-based lotion was the relative efficacy observed in the grooming comb group compared with the louse comb group
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
time frame: 15 days
description: Number of participants with application site reactions
arm group label: Neem-based lotion plus louse comb
arm group type: Experimental
description: Neem-based conditioning lotion plus head louse detection and removal comb
arm group label: Neem-based lotion plus grooming comb
arm group type: Experimental
description: Neem-based conditioning lotion plus regular grooming comb
intervention type: Device
intervention name: Neem-based lotion plus louse comb
description: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb
arm group label: Neem-based lotion plus louse comb
other name: Nice 'n Clear
intervention type: Device
intervention name: Neem-based lotion plus grooming comb
description: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
arm group label: Neem-based lotion plus grooming comb
other name: Nice 'n Clear
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ian F Burgess
role: Principal Investigator
affiliation: Medical Entomology Centre
facility: 
country: United Kingdom
url: http://cordis.europa.eu/result/rcn/46970_en.html
description: Final Report Summary - ClearBrush (A Novel Integrated Ultrasonic Brush and Sonically Activated Lotion to Provide a Full System Approach to the Eradication of the European Head Louse Menace)
responsible party type: Principal Investigator
investigator affiliation: Medical Entomology Centre
investigator full name: Ian F Burgess
investigator title: Director
mesh term: Lice Infestations
sharing ipd: Undecided
ipd description: Contact Principal Investigator
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 