<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/NCT01660321</url>
  </required_header>
  <id_info>
    <org_study_id>SPN-109-11</org_study_id>
    <nct_id>NCT01660321</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation</brief_title>
  <official_title>A Single Treatment, Pharmacokinetic (PK) and Tolerance Study of Natroba (Spinosad) Topical Suspension, 0.9% in Pediatric Subjects 6 Months to 4 Years of Age With an Active Head Lice Infestation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ParaPRO LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ParaPRO LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in&#xD;
      pediatric subjects 6 months to 4 years of age with an active head lice infestation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Postmarketing Requirement Protocol, multicenter, open-label study in pediatric subjects 6&#xD;
      months to 4 years of age with an active head lice infestation designed to determine the&#xD;
      topical absorption and safety of Natroba (spinosad) Topical Suspension, 0.9% for a single, 10&#xD;
      minute treatment for spinosad (Spinosyn A and Spinosyn D) and benzyl alcohol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <phase>Phase 4</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax for Spinosyn A</measure>
    <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
    <description>Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax for Spinosyn A</measure>
    <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
    <description>The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC (0-12) for Spinosyn A</measure>
    <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax for Spinosyn D</measure>
    <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
    <description>Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax for Spinosyn D</measure>
    <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
    <description>The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC (0-12) for Spinosyn D</measure>
    <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax for Benzyl Alcohol</measure>
    <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
    <description>Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax for Benzyl Alcohol</measure>
    <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
    <description>The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC (0-12) for Benzyl Alcohol</measure>
    <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Pediculosis</condition>
  <arm_group>
    <arm_group_label>Natroba</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>spinosad</intervention_name>
    <description>A sufficient amount of Natroba Topical Suspension was applied to completely cover the scalp, worked out to the ends of the hair, and left in place for 10 minutes (±30 seconds), followed by a complete rinse and shampoo.</description>
    <arm_group_label>Natroba</arm_group_label>
    <other_name>Natroba (spinosad) Topical Suspension, 0.9%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, 6 months to 4 years of age.&#xD;
&#xD;
          2. Subjects must have had an active lice infestation including live lice.&#xD;
&#xD;
          3. Individuals in otherwise good general health, free of any systemic or dermatologic&#xD;
             disorders which, in the opinion of the Principal Investigator or designee, would&#xD;
             interfere with the study results or increase the risk of adverse events.&#xD;
&#xD;
          4. A parent (or guardian) must have signed an Informed Consent Form to allow any child to&#xD;
             participate in the study.&#xD;
&#xD;
          5. Subjects must have been available to stay in the clinic for blood draws. Parents or&#xD;
             guardians must have been available to stay in the clinic, with the subject, for the&#xD;
             entire duration of the study.&#xD;
&#xD;
          6. Subjects must have had veins capable of insertion of a Heplock catheter or&#xD;
             withstanding multiple blood draws as determined by the Principal Investigator or&#xD;
             qualified phlebotomist.&#xD;
&#xD;
          7. Normal values (at screening) for serum chemistry and hematology for subjects, unless&#xD;
             the principal Investigator or qualified medical designee determined that the abnormal&#xD;
             value was not clinically significant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of irritation or sensitivity to pediculicide or hair care products or&#xD;
             ingredients.&#xD;
&#xD;
          2. History of known allergy or sensitivity to topical anesthetics including lidocaine and&#xD;
             prilocaine.&#xD;
&#xD;
          3. History of allergy or sensitivity to Heparin.&#xD;
&#xD;
          4. Systemic diseases that could have interfered with the results of this study as&#xD;
             determined by the Principal Investigator or designee.&#xD;
&#xD;
          5. Any condition or illness that, in the opinion of the Investigator or designee, may&#xD;
             have compromised the objective of the protocol or the safety of the subject.&#xD;
&#xD;
          6. The use of antibiotics or other systemic medications within 2 weeks of the screening&#xD;
             visit, which in the opinion of the Investigator or designee could have interfered with&#xD;
             the outcome of the study.&#xD;
&#xD;
          7. Participation in a previous drug study within the past 30 days.&#xD;
&#xD;
          8. Individuals with any visible skin/scalp condition (other than from an active lice&#xD;
             infestation) at the treatment site which would have interfered with the evaluations&#xD;
             according to the opinion of the Investigator or designee.&#xD;
&#xD;
          9. Parents or guardians who, in the opinion of the Investigator, did not understand their&#xD;
             child's requirements for study participation and/or may be likely to exhibit poor&#xD;
             compliance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dowling B Stough, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Burke Pharmaceutical Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey C Seiler, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lice Solutions Resource Network, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Burke Pharmaceutical Research</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lice Solutions Resource Network, Inc.</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>November 2012</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <results_first_submitted>August 20, 2012</results_first_submitted>
  <results_first_submitted_qc>October 18, 2012</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 19, 2012</results_first_posted>
  <last_update_submitted>November 16, 2012</last_update_submitted>
  <last_update_submitted_qc>November 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediculosis capitis</keyword>
  <keyword>Head Lice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lice Infestations</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Overall Study</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Natroba</title>
          <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Natroba</title>
          <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="2" spread="0.9"/>
                  </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="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </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 States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cmax for Spinosyn A</title>
        <description>Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%</description>
        <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
        <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Natroba</title>
            <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax for Spinosyn A</title>
          <description>Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%</description>
          <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
          <units>ng/mL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax for Spinosyn A</title>
        <description>The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.</description>
        <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
        <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Natroba</title>
            <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax for Spinosyn A</title>
          <description>The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.</description>
          <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
          <units>hours</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC (0-12) for Spinosyn A</title>
        <description>Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.</description>
        <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
        <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Natroba</title>
            <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
          </group>
        </group_list>
        <measure>
          <title>AUC (0-12) for Spinosyn A</title>
          <description>Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.</description>
          <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
          <units>ng*hr/mL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax for Spinosyn D</title>
        <description>Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%</description>
        <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
        <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Natroba</title>
            <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax for Spinosyn D</title>
          <description>Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%</description>
          <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
          <units>ng/mL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax for Spinosyn D</title>
        <description>The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.</description>
        <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
        <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Natroba</title>
            <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax for Spinosyn D</title>
          <description>The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.</description>
          <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
          <units>hours</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC (0-12) for Spinosyn D</title>
        <description>Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.</description>
        <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
        <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Natroba</title>
            <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
          </group>
        </group_list>
        <measure>
          <title>AUC (0-12) for Spinosyn D</title>
          <description>Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.</description>
          <population>Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.</population>
          <units>ng* hr/mL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or &lt; 3.0 ng/mL for all samples.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax for Benzyl Alcohol</title>
        <description>Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.</description>
        <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
        <population>Per Protocol</population>
        <group_list>
          <group group_id="O1">
            <title>Natroba</title>
            <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax for Benzyl Alcohol</title>
          <description>Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.</description>
          <population>Per Protocol</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.123" spread="0.3071" lower_limit="0.5" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax for Benzyl Alcohol</title>
        <description>The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.</description>
        <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
        <population>Per Protocol</population>
        <group_list>
          <group group_id="O1">
            <title>Natroba</title>
            <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax for Benzyl Alcohol</title>
          <description>The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.</description>
          <population>Per Protocol</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.3071" lower_limit="0.5" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC (0-12) for Benzyl Alcohol</title>
        <description>Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.</description>
        <time_frame>Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.</time_frame>
        <population>Since the only benzyl alcohol concentrations above Limit of Quantitation (LOQ) (1.0 μg/mL) were for 1 sample each for 4 subjects and 2 non-consecutive samples for 2 subjects, AUC (0-12) was not summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Natroba</title>
            <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
          </group>
        </group_list>
        <measure>
          <title>AUC (0-12) for Benzyl Alcohol</title>
          <description>Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.</description>
          <population>Since the only benzyl alcohol concentrations above Limit of Quantitation (LOQ) (1.0 μg/mL) were for 1 sample each for 4 subjects and 2 non-consecutive samples for 2 subjects, AUC (0-12) was not summarized.</population>
          <units>μg*hr/mL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Since the only benzyl alcohol concentrations above LOQ (1.0 μg/mL) were for 1 sample each for 4 subjects and 2 non-consecutive samples for 2 subjects, AUC 0-12 was not summarized.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the study.</time_frame>
      <desc>All Adverse Events (AEs)occurring during the study were recorded at 0 (pretreatment), 0.5, 1, 3, 6, and 12 hours post-treatment by age group and all subjects. Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using the Medical Dictionary for Regulatory Activities (MedDRA) (v14.0).</desc>
      <group_list>
        <group group_id="E1">
          <title>Natroba</title>
          <description>Natroba (Spinosad) Topical Suspension, 0.9%</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (14.0)</default_vocab>
        <default_assessment>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="9" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="7" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Application Site Pruritus</sub_title>
                <counts group_id="E1" events="13" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="13" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="13" subjects_affected="1" subjects_at_risk="26"/>
              </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>
    <limitations_and_caveats>It is suspected for Subject 02-202, at 0.5 hours, the sample to determine the spinosyn A and spinosyn D concentrations were possibly contaminated with Natroba.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Director, Quality and Regulatory</name_or_title>
      <organization>ParaPro</organization>
      <phone>317-810-6205</phone>
      <email>kerrym@parapro.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/NCT01660321
org study id: SPN-109-11
nct id: NCT01660321
lead sponsor: 
has dmc: No
A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in
      pediatric subjects 6 months to 4 years of age with an active head lice infestation.
A Postmarketing Requirement Protocol, multicenter, open-label study in pediatric subjects 6
      months to 4 years of age with an active head lice infestation designed to determine the
      topical absorption and safety of Natroba (spinosad) Topical Suspension, 0.9% for a single, 10
      minute treatment for spinosad (Spinosyn A and Spinosyn D) and benzyl alcohol.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Cmax for Spinosyn A
time frame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
description: Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%
measure: Tmax for Spinosyn A
time frame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
description: The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.
measure: AUC (0-12) for Spinosyn A
time frame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
description: Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.
measure: Cmax for Spinosyn D
time frame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
description: Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%
measure: Tmax for Spinosyn D
time frame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
description: The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.
measure: AUC (0-12) for Spinosyn D
time frame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
description: Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.
measure: Cmax for Benzyl Alcohol
time frame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
description: Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.
measure: Tmax for Benzyl Alcohol
time frame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
description: The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.
measure: AUC (0-12) for Benzyl Alcohol
time frame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
description: Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.
arm group label: Natroba
arm group type: Experimental
description: Natroba (Spinosad) Topical Suspension, 0.9%
intervention type: Drug
intervention name: spinosad
description: A sufficient amount of Natroba Topical Suspension was applied to completely cover the scalp, worked out to the ends of the hair, and left in place for 10 minutes (±30 seconds), followed by a complete rinse and shampoo.
arm group label: Natroba
other name: Natroba (spinosad) Topical Suspension, 0.9%
criteria: 
gender: All
minimum age: 6 Months
maximum age: 4 Years
healthy volunteers: No
last name: Dowling B Stough, M.D.
role: Principal Investigator
affiliation: Burke Pharmaceutical Research
last name: Jeffrey C Seiler, M.D.
role: Principal Investigator
affiliation: Lice Solutions Resource Network, Inc.
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lice Infestations
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: It is suspected for Subject 02-202, at 0.5 hours, the sample to determine the spinosyn A and spinosyn D concentrations were possibly contaminated with Natroba.
point of contact: 