<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/NCT02978508</url>
  </required_header>
  <id_info>
    <org_study_id>MAP-8184</org_study_id>
    <nct_id>NCT02978508</nct_id>
  </id_info>
  <brief_title>Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.</brief_title>
  <official_title>A Multi-center, Double-blind, Randomized, Parallel-group Study Comparing Permethrin Cream, 5% With Elimite™ in Patients With Active Scabies.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayne Pharma International Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>bioRASI, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayne Pharma International Pty Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, double-blind, randomized, two arm parallel design study. This study&#xD;
      is comprised of two phases: screening and treatment. The screening period will be up to 5&#xD;
      days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will&#xD;
      be randomized to receive either test or reference treatments in a double-blind manner in an&#xD;
      outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and&#xD;
      reference drug arms and will be stratified by site.&#xD;
&#xD;
      Screening will begin at visit 1, during which eligibility will be determined and prohibited&#xD;
      treatments will be discontinued. Randomization will occur following the confirmation of the&#xD;
      eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The&#xD;
      treatment phase will be 28±4 days in duration wherein subject will receive treatment with&#xD;
      investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and&#xD;
      tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and&#xD;
      tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day&#xD;
      28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the&#xD;
      subject will be retreated with the second application of the investigational product.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Systemic absorption of permethrin cream is limited to 0.5% during the first 48 hours&#xD;
      following dermal application. In these settings, a conventional pharmacokinetic human study&#xD;
      to demonstrate that Mayne Permethrin cream (5% w/w) is bioequivalent to the Reference Listed&#xD;
      Drug [RLD] Elimite™ is not appropriate.&#xD;
&#xD;
      This is a clinical endpoint bioequivalence (BE) study for a Permethrin Cream, 5% formulation&#xD;
      for the treatment of active scabies in comparison to Elimite™ Permethrin cream (5% w/w).&#xD;
&#xD;
        -  Test Product: Permethrin Cream, 5%&#xD;
&#xD;
        -  Reference Product: Elimite™ marketed by Prestium Pharma, Inc. (&quot;Prestium&quot;), the branded&#xD;
           subsidiary of Renaissance Pharma.&#xD;
&#xD;
      The infested person, as well as household members are treated at the same time to prevent&#xD;
      re-infestation. In consideration of this recommendation, the household members of the&#xD;
      enrolled subject will be examined and treated at the same time as the enrolled subject with&#xD;
      an FDA-approved generic Permethrin Cream, 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Patients That Are Identified as Cured.</measure>
    <time_frame>Day 28</time_frame>
    <description>To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients That Are Identified as Cured.</measure>
    <time_frame>Day 14</time_frame>
    <description>To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Scabies</condition>
  <arm_group>
    <arm_group_label>Permethrin Cream, 5%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elimite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (&quot;Prestium&quot;), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Permethrin Cream, 5%</intervention_name>
    <description>Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</description>
    <arm_group_label>Permethrin Cream, 5%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elimite</intervention_name>
    <description>Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</description>
    <arm_group_label>Elimite</arm_group_label>
    <other_name>Permethrin Cream, 5%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or non-pregnant, non-lactating female subject at least 12 years of age or older.&#xD;
&#xD;
          2. Subject must have a positive identification for mites, eggs, or mite fecal matter by&#xD;
             microscopic examination of a skin scraping.&#xD;
&#xD;
          3. Subjects must have at least two of the three following: a) excoriations and&#xD;
             inflammatory papules with a typical distribution pattern and localization (webbed&#xD;
             spaces of the fingers, flexor surfaces of the wrists, elbows, axillae, belt line,&#xD;
             feet, skin surface of external genitalia, or areolae); b) presence of burrows; c)&#xD;
             family or contacts with moderate to severe itching which increases during the night.&#xD;
&#xD;
          4. Subjects must be willing to make every effort to immediately disinfect clothes,&#xD;
             towels, and linens and all potentially infected household items upon diagnosis of&#xD;
             infestation to prevent re-infestation.&#xD;
&#xD;
          5. All household members with prolonged physical contact with the subject must be willing&#xD;
             to attend Baseline visit and receive treatment with standard of care if deemed&#xD;
             necessary by the Investigator in order to prevent re-infestation of the subject&#xD;
             enrolled.&#xD;
&#xD;
          6. Subject or representative must read and sign an Institutional Review Board/Independent&#xD;
             Ethics Committee (IRB/IEC) approved Informed Consent Form (ICF); for minor subjects&#xD;
             (18 years or younger in most states) the parent or legal guardian should sign the ICF&#xD;
             and the child will be required to sign the Assent Form that will written in such a way&#xD;
             as to be understandable to a child.&#xD;
&#xD;
          7. Subject must be able to apply study product to self. If the subject is a child, then&#xD;
             parent/guardian will apply study product to him/her.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant as shown in a urine pregnancy test at the Baseline visit,&#xD;
             prior to randomization, or lactating, or of childbearing potential (for purpose of&#xD;
             this study a female of childbearing potential is considered to be not surgically&#xD;
             sterile or postmenopausal for at least 1 year) who are not using or do not agree to&#xD;
             use an acceptable form of contraception (oral /implant /injectable /transdermal&#xD;
             contraceptives, intrauterine device (IUD), condom, diaphragm, or abstinence) during&#xD;
             the study, or who intends to become pregnant during the study; contraceptive method&#xD;
             must also be consistent throughout the study.&#xD;
&#xD;
          2. Treatment for scabies &lt;4 weeks prior to enrollment, including permethrin, benzyl&#xD;
             alcohol, lindane, crotamiton, malathion, and ivermectin.&#xD;
&#xD;
          3. Use of prohibited medications:&#xD;
&#xD;
               -  Topical or oral scabicidal/antiparasitic treatment including: permethrin, benzyl&#xD;
                  alcohol, benzyl benzoate, lindane, crotamiton, malathion, ivermectin,&#xD;
                  precipitated sulfur, albendazole, keratolytic cream, tea tree oil, or oil of the&#xD;
                  leaves of Lippia multiflora Moldenke within 28 days of visit 2.&#xD;
&#xD;
               -  Systemic corticosteroids (including inhaled steroids) taken within 14 days of&#xD;
                  visit 2.&#xD;
&#xD;
               -  Topical corticosteroids including hydrocortisone taken within 24 hours of visit&#xD;
                  2.&#xD;
&#xD;
               -  Topical antipruritics, including antihistamines within 24 hours of any study&#xD;
                  visits.&#xD;
&#xD;
               -  Oral antihistamine including diphenhydramine (Benadryl) taken within 24 hours of&#xD;
                  any study visits.&#xD;
&#xD;
               -  Topical antibiotics including mupirocin taken within 24 hours of any study&#xD;
                  visits.&#xD;
&#xD;
          4. Patients with immunosuppressive disorders requiring therapy, severe systemic disease,&#xD;
             history of HIV infection and/or seizures.&#xD;
&#xD;
          5. Patients with crusted/Norwegian scabies.&#xD;
&#xD;
          6. Presence of underlying skin disease that would obscure evaluation of the papules and&#xD;
             burrows associated with scabies infection as determined by the Investigator.&#xD;
&#xD;
          7. Presence of severe cutaneous bacterial or fungal infections requiring therapy&#xD;
             (including systemic and topical antibiotics) as determined by the Investigator.&#xD;
&#xD;
          8. Sensitivity or allergy to Permethrin Cream or any of its components, synthetic&#xD;
             pyrethroids, pyrethrin, chrysanthemums or ragweed.&#xD;
&#xD;
          9. A recent (less than 1 year) history of alcoholism, drug abuse, or other problems which&#xD;
             would likely make the subject unreliable for the study.&#xD;
&#xD;
         10. Participation in another investigational study or using any investigational product&#xD;
             within the 30 days prior to the Baseline visit.&#xD;
&#xD;
         11. Participation of family member, or another member of the household (including regular&#xD;
             bedmates) in the current study.&#xD;
&#xD;
         12. Total number of bedmates and family members with prolonged physical contact is greater&#xD;
             than 6 (including study subject).&#xD;
&#xD;
         13. Any employees of the clinic, investigators, or family members of the study staff.&#xD;
&#xD;
         14. Patients who in the opinion of the Investigator would be non-compliant with the&#xD;
             requirements of the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Phoevos Hughes, JD</last_name>
    <role>Study Director</role>
    <affiliation>bioRASI, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LCC Medical Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southcoast Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Columbia Research</name>
      <address>
        <city>Richland</city>
        <state>Washington</state>
        <zip>99352</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>August 13, 2020</results_first_submitted>
  <results_first_submitted_qc>August 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 2, 2020</results_first_posted>
  <last_update_submitted>August 28, 2020</last_update_submitted>
  <last_update_submitted_qc>August 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scabies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Permethrin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 14, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT02978508/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT02978508/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Permethrin Cream, 5%</title>
          <description>Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.&#xD;
Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</description>
        </group>
        <group group_id="P2">
          <title>Elimite</title>
          <description>Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (&quot;Prestium&quot;), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.&#xD;
Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </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>Permethrin Cream, 5%</title>
          <description>Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.&#xD;
Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</description>
        </group>
        <group group_id="B2">
          <title>Elimite</title>
          <description>Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (&quot;Prestium&quot;), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.&#xD;
Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</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="70"/>
            <count group_id="B2" value="70"/>
            <count group_id="B3" value="140"/>
          </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="36" spread="15.70"/>
                    <measurement group_id="B2" value="36.7" spread="16.23"/>
                    <measurement group_id="B3" value="36.3" spread="15.92"/>
                  </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="41"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="74"/>
                  </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="52"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </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>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <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>Visual Examination of Lesions</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Patients That Are Identified as Cured.</title>
        <description>To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.</description>
        <time_frame>Day 28</time_frame>
        <population>2 subjects were not included in the per protocol anaylis for the following reasons: 101-036: Subject rinsed off the IP after 6:45 mins of application. As per protocol IP is to be rinsed off after at least 8-14 hours of application.&#xD;
103003: Subject's visit 3 and 5 was performed out of allowed visit window period.</population>
        <group_list>
          <group group_id="O1">
            <title>Permethrin Cream, 5%</title>
            <description>Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.&#xD;
Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</description>
          </group>
          <group group_id="O2">
            <title>Elimite</title>
            <description>Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (&quot;Prestium&quot;), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.&#xD;
Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients That Are Identified as Cured.</title>
          <description>To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.</description>
          <population>2 subjects were not included in the per protocol anaylis for the following reasons: 101-036: Subject rinsed off the IP after 6:45 mins of application. As per protocol IP is to be rinsed off after at least 8-14 hours of application.&#xD;
103003: Subject's visit 3 and 5 was performed out of allowed visit window period.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients That Are Identified as Cured.</title>
        <description>To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.</description>
        <time_frame>Day 14</time_frame>
        <population>2 subjects were not included in the per protocol anaylis for the following reasons: 101-036: Subject rinsed off the IP after 6:45 mins of application. As per protocol IP is to be rinsed off after at least 8-14 hours of application.&#xD;
103003: Subject's visit 3 and 5 was performed out of allowed visit window period.</population>
        <group_list>
          <group group_id="O1">
            <title>Permethrin Cream, 5%</title>
            <description>Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.&#xD;
Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</description>
          </group>
          <group group_id="O2">
            <title>Elimite</title>
            <description>Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (&quot;Prestium&quot;), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.&#xD;
Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients That Are Identified as Cured.</title>
          <description>To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.</description>
          <population>2 subjects were not included in the per protocol anaylis for the following reasons: 101-036: Subject rinsed off the IP after 6:45 mins of application. As per protocol IP is to be rinsed off after at least 8-14 hours of application.&#xD;
103003: Subject's visit 3 and 5 was performed out of allowed visit window period.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 months from first subject first visit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Permethrin Cream, 5%</title>
          <description>Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.&#xD;
Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</description>
        </group>
        <group group_id="E2">
          <title>Elimite</title>
          <description>Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (&quot;Prestium&quot;), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.&#xD;
Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.</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="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="8" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Upper Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament Sprain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning Sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </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>Associate Director, Clinical Operations</name_or_title>
      <organization>Mayne Pharma LLC</organization>
      <phone>919 573 7948</phone>
      <email>phoevos.hughes@maynepharma.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/NCT02978508
org study id: MAP-8184
nct id: NCT02978508
lead sponsor: 
collaborator: 
has dmc: No
This is a multi-center, double-blind, randomized, two arm parallel design study. This study
      is comprised of two phases: screening and treatment. The screening period will be up to 5
      days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will
      be randomized to receive either test or reference treatments in a double-blind manner in an
      outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and
      reference drug arms and will be stratified by site.

      Screening will begin at visit 1, during which eligibility will be determined and prohibited
      treatments will be discontinued. Randomization will occur following the confirmation of the
      eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The
      treatment phase will be 28±4 days in duration wherein subject will receive treatment with
      investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and
      tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and
      tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day
      28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the
      subject will be retreated with the second application of the investigational product.
Systemic absorption of permethrin cream is limited to 0.5% during the first 48 hours
      following dermal application. In these settings, a conventional pharmacokinetic human study
      to demonstrate that Mayne Permethrin cream (5% w/w) is bioequivalent to the Reference Listed
      Drug [RLD] Elimite™ is not appropriate.

      This is a clinical endpoint bioequivalence (BE) study for a Permethrin Cream, 5% formulation
      for the treatment of active scabies in comparison to Elimite™ Permethrin cream (5% w/w).

        -  Test Product: Permethrin Cream, 5%

        -  Reference Product: Elimite™ marketed by Prestium Pharma, Inc. ("Prestium"), the branded
           subsidiary of Renaissance Pharma.

      The infested person, as well as household members are treated at the same time to prevent
      re-infestation. In consideration of this recommendation, the household members of the
      enrolled subject will be examined and treated at the same time as the enrolled subject with
      an FDA-approved generic Permethrin Cream, 5%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of Patients That Are Identified as Cured.
time frame: Day 28
description: To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
measure: Proportion of Patients That Are Identified as Cured.
time frame: Day 14
description: To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
arm group label: Permethrin Cream, 5%
arm group type: Experimental
description: Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.
arm group label: Elimite
arm group type: Active Comparator
description: Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.
intervention type: Drug
intervention name: Permethrin Cream, 5%
description: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
arm group label: Permethrin Cream, 5%
intervention type: Drug
intervention name: Elimite
description: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
arm group label: Elimite
other name: Permethrin Cream, 5%
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Phoevos Hughes, JD
role: Study Director
affiliation: bioRASI, LLC
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Scabies
mesh term: Permethrin
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 