<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/NCT02997904</url>
  </required_header>
  <id_info>
    <org_study_id>PP-16-001</org_study_id>
    <nct_id>NCT02997904</nct_id>
  </id_info>
  <brief_title>A Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit on Pediatric and Adult Subjects</brief_title>
  <official_title>A Randomized Sham Controlled Double Blinded Single Site Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit for the Removal of Human Head Lice and Eggs on Pediatric and Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Piedmont Pharmaceuticals, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lice Solutions Resource Network (LSRN) Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Piedmont Pharmaceuticals, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically&#xD;
      superior to a sham control with one hour of combing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice&#xD;
      infestations in children and adult subjects under simulated real world conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing</measure>
    <time_frame>1 hour</time_frame>
    <description>A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Number of Lice Removed, Total Number of Eggs Removed</measure>
    <time_frame>1 hour</time_frame>
    <description>Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Pediculus Capitis</condition>
  <arm_group>
    <arm_group_label>Resultz Lice and Egg Elimination Kit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resultz combing solution, head lice comb and instructions for use in a kit: apply liquid then comb out for 1 hour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Lice and Egg Elimination Kit</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20% glycerin combing solution, comb and instructions for use in a kit: apply liquid then comb out for 1 hour</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Apply Liquid Then Comb Out</intervention_name>
    <description>Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour</description>
    <arm_group_label>Placebo Lice and Egg Elimination Kit</arm_group_label>
    <arm_group_label>Resultz Lice and Egg Elimination Kit</arm_group_label>
    <other_name>Resultz Application</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have active head lice infestations (at least 1 live louse and eggs)&#xD;
&#xD;
          -  Good general health based on medical history&#xD;
&#xD;
          -  Each subject has to be consented&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any condition that would compromise the study&#xD;
&#xD;
          -  History of irritation or sensitivity to pediculicides or hair care products&#xD;
&#xD;
          -  Subjects with cranial or facial implants&#xD;
&#xD;
          -  Subjects who have received radiation within the last 6 months&#xD;
&#xD;
          -  Subjects with history of heart disease&#xD;
&#xD;
          -  Subjects with history of epilepsy or seizure disorders&#xD;
&#xD;
          -  Subjects with neuro-stimulator or pacemaker&#xD;
&#xD;
          -  Subject with hair that staff cannot comb&#xD;
&#xD;
          -  Subject previously treated in study in last 30 days&#xD;
&#xD;
          -  Use of lice treatment in past 2 weeks&#xD;
&#xD;
          -  Subject unable to sense pain&#xD;
&#xD;
          -  Subject unable to communicate pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katie Shepherd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lice Solutions Resource Network Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lice Solution Resource Network Research</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <results_first_submitted>June 28, 2017</results_first_submitted>
  <results_first_submitted_qc>July 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2017</results_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lice comb</keyword>
  <keyword>human head lice infestations</keyword>
  <keyword>combing solution</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Resultz Lice and Egg Removal Kit</title>
          <description>Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour&#xD;
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb</description>
        </group>
        <group group_id="P2">
          <title>Sham Lice and Egg Removal Kit</title>
          <description>20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour&#xD;
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored 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="51"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Resultz Lice and Egg Removal Kit</title>
          <description>Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour&#xD;
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb</description>
        </group>
        <group group_id="B2">
          <title>Sham Lice and Egg Removal Kit</title>
          <description>20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour&#xD;
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored 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="51"/>
            <count group_id="B2" value="49"/>
            <count group_id="B3" value="100"/>
          </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="16.3" spread="13.5"/>
                    <measurement group_id="B2" value="17.8" spread="12.1"/>
                    <measurement group_id="B3" value="16.9" spread="12.9"/>
                  </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="37"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="19"/>
                  </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="40"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing</title>
        <description>A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.</description>
        <time_frame>1 hour</time_frame>
        <population>Intent To Treat; including all subjects who were enrolled in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Resultz Lice and Egg Elimination Kit</title>
            <description>Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour&#xD;
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb</description>
          </group>
          <group group_id="O2">
            <title>Sham Lice and Egg Elimination Kit</title>
            <description>20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour&#xD;
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb</description>
          </group>
        </group_list>
        <measure>
          <title>The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing</title>
          <description>A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.</description>
          <population>Intent To Treat; including all subjects who were enrolled in the study.</population>
          <units>number of lice and eggs removed</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.3" spread="61.2"/>
                    <measurement group_id="O2" value="26.1" spread="25.6"/>
                  </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>Ho: Total Number of lice and eggs removed with Resultz® ≤ Total number of lice and eggs removed with sham control Ha: Total Number of lice and eggs removed with Resultz® &gt; Total Number of lice and eggs removed with sham control</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>1.0058</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2131</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.5829</ci_lower_limit>
            <ci_upper_limit>1.4288</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Lice Removed, Total Number of Eggs Removed</title>
        <description>Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately</description>
        <time_frame>1 hour</time_frame>
        <population>Intent To Treat; including all subjects enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Number or Lice Removed by Resultz</title>
            <description>Total number of lice removed after one hour of combing with Resultz; analyzed separately</description>
          </group>
          <group group_id="O2">
            <title>Number of Lice Removed by Control</title>
            <description>Total number of lice removed after one hour of combing by control; analyzed separately</description>
          </group>
          <group group_id="O3">
            <title>Number of Eggs Removed by Resultz</title>
            <description>Total number of eggs removed after one hour of combing, analyzed separately</description>
          </group>
          <group group_id="O4">
            <title>Number of Eggs Removed by Control</title>
            <description>Total number of eggs removed after one hour of combing by control, analyzed separately</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Lice Removed, Total Number of Eggs Removed</title>
          <description>Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately</description>
          <population>Intent To Treat; including all subjects enrolled</population>
          <units>Number of Lice or Number of Eggs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" spread="43.6"/>
                    <measurement group_id="O2" value="12" spread="15.1"/>
                    <measurement group_id="O3" value="31" spread="22.3"/>
                    <measurement group_id="O4" value="14.1" spread="11.8"/>
                  </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>Comparison of total number of lice removed and total number of eggs removed were analyzed separately</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>The P-Values were &lt;0.0001 in both comparison groups; total number lice removed and total number of eggs removed</p_value_desc>
            <method>GLIMMX</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>1.2084</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04670</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1157</ci_lower_limit>
            <ci_upper_limit>1.3011</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>GLIMMX</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>0.7899</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04565</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6993</ci_lower_limit>
            <ci_upper_limit>0.8805</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 Day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Resultz Lice and Egg Removal Kit</title>
          <description>Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour&#xD;
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb</description>
        </group>
        <group group_id="E2">
          <title>Sham Lice and Egg Removal Kit</title>
          <description>20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour&#xD;
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored 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="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </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="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </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>Not without sponsor permission</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Kathy Palma</name_or_title>
      <organization>Piedmont Pharmaceuticals</organization>
      <phone>336 544 0320 ext 202</phone>
      <email>kpalma@piedmontpharma.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/NCT02997904
org study id: PP-16-001
nct id: NCT02997904
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically
      superior to a sham control with one hour of combing.
Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice
      infestations in children and adult subjects under simulated real world conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing
time frame: 1 hour
description: A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.
measure: Total Number of Lice Removed, Total Number of Eggs Removed
time frame: 1 hour
description: Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately
arm group label: Resultz Lice and Egg Elimination Kit
arm group type: Experimental
description: Resultz combing solution, head lice comb and instructions for use in a kit: apply liquid then comb out for 1 hour
arm group label: Placebo Lice and Egg Elimination Kit
arm group type: Placebo Comparator
description: 20% glycerin combing solution, comb and instructions for use in a kit: apply liquid then comb out for 1 hour
intervention type: Device
intervention name: Apply Liquid Then Comb Out
description: Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour
arm group label: Placebo Lice and Egg Elimination Kit
arm group label: Resultz Lice and Egg Elimination Kit
other name: Resultz Application
criteria: 
gender: All
minimum age: 2 Years
maximum age: 90 Years
healthy volunteers: No
last name: Katie Shepherd
role: Principal Investigator
affiliation: Lice Solutions Resource Network Research
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 