<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/NCT01712360</url>
  </required_header>
  <id_info>
    <org_study_id>MUS 90200/1023/0</org_study_id>
    <secondary_id>Tinea Pedis and Cruris</secondary_id>
    <nct_id>NCT01712360</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis</brief_title>
  <official_title>An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of NAFT-500 in Pediatric Subjects With Tinea Cruris and Tinea Pedis and NAFT-600 in Pediatric Subjects With Tinea Pedis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merz North America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merz North America, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to see how the body is affected when a study drug is applied to both&#xD;
      feet if the subject has athlete's foot or to both feet and the groin area if the subject has&#xD;
      both athlete's foot and jock itch. Safety of the drug and how well the drug works will also&#xD;
      be measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study population, diagnosis, and main criteria for inclusion:&#xD;
&#xD;
      Tinea pedis and Tinea cruris (NAFT-500):&#xD;
&#xD;
      Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with&#xD;
      Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH)&#xD;
      analysis from both the feet and bikini area. Both cases (feet and bikini area) must be&#xD;
      characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional,&#xD;
      approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will&#xD;
      serve as a control.&#xD;
&#xD;
      Tinea pedis (NAFT-600):&#xD;
&#xD;
      Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with&#xD;
      Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both&#xD;
      feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection.&#xD;
      Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same&#xD;
      condition will serve as a control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose</measure>
    <time_frame>Day 1 and Day 14</time_frame>
    <description>Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:&#xD;
- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.&#xD;
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:&#xD;
- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose</measure>
    <time_frame>Day 1 and Day 14</time_frame>
    <description>Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:&#xD;
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.&#xD;
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:&#xD;
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy Variables</measure>
    <time_frame>Day 28</time_frame>
    <description>Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).&#xD;
Efficacy variables to be analyzed:&#xD;
Complete cure&#xD;
Treatment effectiveness&#xD;
Mycological cure&#xD;
Clinical success&#xD;
Clinical cure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy Variables</measure>
    <time_frame>Day 28</time_frame>
    <description>Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).&#xD;
Efficacy variables to be analyzed:&#xD;
- Subject satisfaction</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Tinea Pedis</condition>
  <condition>Tinea Cruris</condition>
  <arm_group>
    <arm_group_label>NAFT500 (pediatric)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical once a day for two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAFT600 (pediatric)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical once a day for two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAFT500 (adult)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical once a day for two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAFT600 (adult)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical once a day for two weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NAFT500 (pediatric)</intervention_name>
    <description>Applied to both feet and groin area</description>
    <arm_group_label>NAFT500 (pediatric)</arm_group_label>
    <other_name>NAFT500</other_name>
    <other_name>naftifine</other_name>
    <other_name>naftifine hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NAFT600 (pediatric)</intervention_name>
    <description>Applied to both feet only</description>
    <arm_group_label>NAFT600 (pediatric)</arm_group_label>
    <other_name>NAFT600</other_name>
    <other_name>naftifine</other_name>
    <other_name>naftifine hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NAFT500 (adult)</intervention_name>
    <description>Applied to both feet and groin area</description>
    <arm_group_label>NAFT500 (adult)</arm_group_label>
    <other_name>NAFT500</other_name>
    <other_name>naftifine</other_name>
    <other_name>naftifine hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NAFT600 (adult)</intervention_name>
    <description>Applied to both feet</description>
    <arm_group_label>NAFT600 (adult)</arm_group_label>
    <other_name>NAFT600</other_name>
    <other_name>naftifine</other_name>
    <other_name>naftifine hydrochloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500;&#xD;
             both conditions must be characterized by clinical evidence of a Tinea infection.&#xD;
&#xD;
          -  Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be&#xD;
             characterized by clinical evidence of a Tinea infection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A known hypersensitivity to study medications or their components&#xD;
&#xD;
          -  Any severe condition of Tinea pedis (incapacitating)&#xD;
&#xD;
          -  Any dermatological disease and or condition in the treatment or surrounding area that&#xD;
             may prevent application of the study product such as foot psoriasis, corns and /or&#xD;
             callus involving any web spaces, or atopic or contact dermatitis&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Any history or current evidence (physical or laboratory) of anemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Fleischer, MD</last_name>
    <role>Study Director</role>
    <affiliation>Merz Pharmaceutical, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Merz Investigative Site #001272</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site #001261</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site #180001</name>
      <address>
        <city>Santo Domingo</city>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site #504001</name>
      <address>
        <city>San Pedro Sula</city>
        <country>Honduras</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Dominican Republic</country>
    <country>Honduras</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>April 14, 2016</results_first_submitted>
  <results_first_submitted_qc>June 3, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 14, 2016</results_first_posted>
  <last_update_submitted>June 3, 2016</last_update_submitted>
  <last_update_submitted_qc>June 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tinea Pedis</keyword>
  <keyword>Tinea Cruris</keyword>
  <keyword>Athlete foot</keyword>
  <keyword>Jock itch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinea</mesh_term>
    <mesh_term>Tinea Pedis</mesh_term>
    <mesh_term>Tinea cruris</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naftifine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NAFT500 (Pediatric)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT500 (pediatric): Applied to both feet and groin area</description>
        </group>
        <group group_id="P2">
          <title>NAFT600 (Pediatric)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT600 (pediatric): Applied to both feet only</description>
        </group>
        <group group_id="P3">
          <title>NAFT500 (Adult)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT500 (adult): Applied to both feet and groin area</description>
        </group>
        <group group_id="P4">
          <title>NAFT600 (Adult)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT600 (adult): Applied to both feet</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set which is the subset of subjects who have been exposed to the study medication at least once</population>
      <group_list>
        <group group_id="B1">
          <title>NAFT500 (Pediatric)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT500 (pediatric): Applied to both feet and groin area</description>
        </group>
        <group group_id="B2">
          <title>NAFT600 (Pediatric)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT600 (pediatric): Applied to both feet only</description>
        </group>
        <group group_id="B3">
          <title>NAFT500 (Adult)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT500 (adult): Applied to both feet and groin area</description>
        </group>
        <group group_id="B4">
          <title>NAFT600 (Adult)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT600 (adult): Applied to both feet</description>
        </group>
        <group group_id="B5">
          <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="22"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="56"/>
          </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="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" 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="14.8" spread="1.5"/>
                    <measurement group_id="B2" value="14.7" spread="1.7"/>
                    <measurement group_id="B3" value="38.7" spread="6.5"/>
                    <measurement group_id="B4" value="31.7" spread="11.2"/>
                    <measurement group_id="B5" value="19.1" spread="9.6"/>
                  </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="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="45"/>
                  </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="0"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Honduras</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dominican Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose</title>
        <description>Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:&#xD;
- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.&#xD;
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:&#xD;
- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state</description>
        <time_frame>Day 1 and Day 14</time_frame>
        <population>Pharmacokinetic analysis set (PKS), defined as the subset of subjects in the safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.</population>
        <group_list>
          <group group_id="O1">
            <title>NAFT500 (Pediatric)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (pediatric): Applied to both feet and groin area</description>
          </group>
          <group group_id="O2">
            <title>NAFT600 (Pediatric)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT600 (pediatric): Applied to both feet only</description>
          </group>
          <group group_id="O3">
            <title>NAFT500 (Adult)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (adult): Applied to both feet and groin area</description>
          </group>
          <group group_id="O4">
            <title>NAFT600 (Adult)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT600 (adult): Applied to both feet</description>
          </group>
        </group_list>
        <measure>
          <title>Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose</title>
          <description>Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:&#xD;
- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.&#xD;
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:&#xD;
- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state</description>
          <population>Pharmacokinetic analysis set (PKS), defined as the subset of subjects in the safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.</population>
          <units>h*pg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AUC0-24 Day 1, Single Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138262.2" spread="50.2"/>
                    <measurement group_id="O2" value="15890.1" spread="211.6"/>
                    <measurement group_id="O3" value="68634.2" spread="95.4"/>
                    <measurement group_id="O4" value="17213.9" spread="88.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUCτ,ss Day 14 Multiple Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="192485.4" spread="74.9"/>
                    <measurement group_id="O2" value="60038.5" spread="131.1"/>
                    <measurement group_id="O3" value="124596.0" spread="49.9"/>
                    <measurement group_id="O4" value="72849.8" spread="71.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy Variables</title>
        <description>Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).&#xD;
Efficacy variables to be analyzed:&#xD;
Complete cure&#xD;
Treatment effectiveness&#xD;
Mycological cure&#xD;
Clinical success&#xD;
Clinical cure</description>
        <time_frame>Day 28</time_frame>
        <population>Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.</population>
        <group_list>
          <group group_id="O1">
            <title>NAFT500 (Pediatric, Foot)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (pediatric): Applied to both feet and groin area</description>
          </group>
          <group group_id="O2">
            <title>NAFT500 (Adult, Foot)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (adult): Applied to both feet and groin area</description>
          </group>
          <group group_id="O3">
            <title>NAFT500 (Pediatric, Groin)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (pediatric): Applied to both feet and groin area</description>
          </group>
          <group group_id="O4">
            <title>NAFT500 (Adult, Groin)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (adult): Applied to both feet and groin area</description>
          </group>
          <group group_id="O5">
            <title>NAFT600 (Pediatric)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT600 (pediatric): Applied to both feet only</description>
          </group>
          <group group_id="O6">
            <title>NAFT600 (Adult)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT600 (adult): Applied to both feet</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy Variables</title>
          <description>Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).&#xD;
Efficacy variables to be analyzed:&#xD;
Complete cure&#xD;
Treatment effectiveness&#xD;
Mycological cure&#xD;
Clinical success&#xD;
Clinical cure</description>
          <population>Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.</population>
          <units>Percentage (%) of subjects (90% CI)</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete Cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.1" lower_limit="39.5" upper_limit="76.7"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="63.6" lower_limit="43.9" upper_limit="80.4"/>
                    <measurement group_id="O4" value="16.7" lower_limit="0.9" upper_limit="58.2"/>
                    <measurement group_id="O5" value="27.3" lower_limit="12.6" upper_limit="46.8"/>
                    <measurement group_id="O6" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Effectiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" lower_limit="43.9" upper_limit="80.4"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="63.6" lower_limit="43.9" upper_limit="80.4"/>
                    <measurement group_id="O4" value="50.0" lower_limit="15.3" upper_limit="84.7"/>
                    <measurement group_id="O5" value="54.5" lower_limit="35.3" upper_limit="72.9"/>
                    <measurement group_id="O6" value="20.0" lower_limit="1.0" upper_limit="65.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mycological Cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.2" lower_limit="48.5" upper_limit="84.0"/>
                    <measurement group_id="O2" value="16.7" lower_limit="0.9" upper_limit="58.2"/>
                    <measurement group_id="O3" value="72.7" lower_limit="53.2" upper_limit="87.4"/>
                    <measurement group_id="O4" value="66.7" lower_limit="27.1" upper_limit="93.7"/>
                    <measurement group_id="O5" value="63.6" lower_limit="43.9" upper_limit="80.4"/>
                    <measurement group_id="O6" value="20.0" lower_limit="1.0" upper_limit="65.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9" lower_limit="74.1" upper_limit="98.4"/>
                    <measurement group_id="O2" value="66.7" lower_limit="27.1" upper_limit="93.7"/>
                    <measurement group_id="O3" value="90.9" lower_limit="74.1" upper_limit="98.4"/>
                    <measurement group_id="O4" value="66.7" lower_limit="27.1" upper_limit="93.7"/>
                    <measurement group_id="O5" value="81.8" lower_limit="63.1" upper_limit="93.5"/>
                    <measurement group_id="O6" value="80" lower_limit="34.3" upper_limit="99.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.8" lower_limit="63.1" upper_limit="93.5"/>
                    <measurement group_id="O2" value="16.7" lower_limit="0.9" upper_limit="58.2"/>
                    <measurement group_id="O3" value="81.8" lower_limit="63.1" upper_limit="93.5"/>
                    <measurement group_id="O4" value="33.3" lower_limit="6.3" upper_limit="72.9"/>
                    <measurement group_id="O5" value="40.9" lower_limit="23.3" upper_limit="60.5"/>
                    <measurement group_id="O6" value="20.0" lower_limit="1.0" upper_limit="65.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose</title>
        <description>Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:&#xD;
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.&#xD;
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:&#xD;
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).</description>
        <time_frame>Day 1 and Day 14</time_frame>
        <population>Pharmacokinetic analysis set (PKS), defined as the subset of subjects in safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.</population>
        <group_list>
          <group group_id="O1">
            <title>NAFT500 (Pediatric)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (pediatric): Applied to both feet and groin area</description>
          </group>
          <group group_id="O2">
            <title>NAFT600 (Pediatric)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT600 (pediatric): Applied to both feet only</description>
          </group>
          <group group_id="O3">
            <title>NAFT500 (Adult)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (adult): Applied to both feet and groin area</description>
          </group>
          <group group_id="O4">
            <title>NAFT600 (Adult)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT600 (adult): Applied to both feet</description>
          </group>
        </group_list>
        <measure>
          <title>Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose</title>
          <description>Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:&#xD;
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.&#xD;
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:&#xD;
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).</description>
          <population>Pharmacokinetic analysis set (PKS), defined as the subset of subjects in safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.</population>
          <units>pg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cmax Day 1, Single Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9213.35" spread="48.4"/>
                    <measurement group_id="O2" value="1397.77" spread="153.8"/>
                    <measurement group_id="O3" value="3983.34" spread="83.0"/>
                    <measurement group_id="O4" value="1741.02" spread="69.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cmax, SS Day 14 Multiple Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12727.36" spread="67.2"/>
                    <measurement group_id="O2" value="3813.38" spread="153.9"/>
                    <measurement group_id="O3" value="6826.70" spread="51.3"/>
                    <measurement group_id="O4" value="3538.84" spread="73.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy Variables</title>
        <description>Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).&#xD;
Efficacy variables to be analyzed:&#xD;
- Subject satisfaction</description>
        <time_frame>Day 28</time_frame>
        <population>Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.</population>
        <group_list>
          <group group_id="O1">
            <title>NAFT500 (Pediatric, Foot)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (pediatric): Applied to both feet and groin area</description>
          </group>
          <group group_id="O2">
            <title>NAFT500 (Adult, Foot)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (adult): Applied to both feet and groin area</description>
          </group>
          <group group_id="O3">
            <title>NAFT500 (Pediatric, Groin)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (pediatric): Applied to both feet and groin area</description>
          </group>
          <group group_id="O4">
            <title>NAFT500 (Adult, Groin)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT500 (adult): Applied to both feet and groin area</description>
          </group>
          <group group_id="O5">
            <title>NAFT600 (Pediatric)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT600 (pediatric): Applied to both feet only</description>
          </group>
          <group group_id="O6">
            <title>NAFT600 (Adult)</title>
            <description>Topical once a day for two weeks&#xD;
NAFT600 (adult): Applied to both feet</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy Variables</title>
          <description>Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).&#xD;
Efficacy variables to be analyzed:&#xD;
- Subject satisfaction</description>
          <population>Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.</population>
          <units>Percentage (%) of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Excellent Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.8"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="86.4"/>
                    <measurement group_id="O4" value="16.7"/>
                    <measurement group_id="O5" value="54.5"/>
                    <measurement group_id="O6" value="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6"/>
                    <measurement group_id="O2" value="83.3"/>
                    <measurement group_id="O3" value="13.6"/>
                    <measurement group_id="O4" value="50.0"/>
                    <measurement group_id="O5" value="36.4"/>
                    <measurement group_id="O6" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="33.3"/>
                    <measurement group_id="O5" value="4.5"/>
                    <measurement group_id="O6" value="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>NAFT500 (Pediatric)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT500 (pediatric): Applied to both feet and groin area</description>
        </group>
        <group group_id="E2">
          <title>NAFT600 (Pediatric)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT600 (pediatric): Applied to both feet only</description>
        </group>
        <group group_id="E3">
          <title>NAFT500 (Adult)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT500 (adult): Applied to both feet and groin area</description>
        </group>
        <group group_id="E4">
          <title>NAFT600 (Adult)</title>
          <description>Topical once a day for two weeks&#xD;
NAFT600 (adult): Applied to both feet</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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</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="4" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headaches</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </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>Ashlee Duncan</name_or_title>
      <organization>Merz North America, Inc.</organization>
      <phone>984-222-6040</phone>
      <email>Ashlee.Duncan@merz.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/NCT01712360
org study id: MUS 90200/1023/0
secondary id: Tinea Pedis and Cruris
nct id: NCT01712360
lead sponsor: 
has dmc: No
This study is being done to see how the body is affected when a study drug is applied to both
      feet if the subject has athlete's foot or to both feet and the groin area if the subject has
      both athlete's foot and jock itch. Safety of the drug and how well the drug works will also
      be measured.
Study population, diagnosis, and main criteria for inclusion:

      Tinea pedis and Tinea cruris (NAFT-500):

      Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with
      Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH)
      analysis from both the feet and bikini area. Both cases (feet and bikini area) must be
      characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional,
      approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will
      serve as a control.

      Tinea pedis (NAFT-600):

      Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with
      Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both
      feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection.
      Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same
      condition will serve as a control.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
time frame: Day 1 and Day 14
description: Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:
- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:
- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state
measure: Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
time frame: Day 1 and Day 14
description: Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).
measure: Efficacy Variables
time frame: Day 28
description: Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).
Efficacy variables to be analyzed:
Complete cure
Treatment effectiveness
Mycological cure
Clinical success
Clinical cure
measure: Efficacy Variables
time frame: Day 28
description: Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).
Efficacy variables to be analyzed:
- Subject satisfaction
arm group label: NAFT500 (pediatric)
arm group type: Experimental
description: Topical once a day for two weeks
arm group label: NAFT600 (pediatric)
arm group type: Experimental
description: Topical once a day for two weeks
arm group label: NAFT500 (adult)
arm group type: Experimental
description: Topical once a day for two weeks
arm group label: NAFT600 (adult)
arm group type: Experimental
description: Topical once a day for two weeks
intervention type: Drug
intervention name: NAFT500 (pediatric)
description: Applied to both feet and groin area
arm group label: NAFT500 (pediatric)
other name: NAFT500
other name: naftifine
other name: naftifine hydrochloride
intervention type: Drug
intervention name: NAFT600 (pediatric)
description: Applied to both feet only
arm group label: NAFT600 (pediatric)
other name: NAFT600
other name: naftifine
other name: naftifine hydrochloride
intervention type: Drug
intervention name: NAFT500 (adult)
description: Applied to both feet and groin area
arm group label: NAFT500 (adult)
other name: NAFT500
other name: naftifine
other name: naftifine hydrochloride
intervention type: Drug
intervention name: NAFT600 (adult)
description: Applied to both feet
arm group label: NAFT600 (adult)
other name: NAFT600
other name: naftifine
other name: naftifine hydrochloride
criteria: 
gender: All
minimum age: 12 Years
maximum age: 65 Years
healthy volunteers: No
last name: Alan Fleischer, MD
role: Study Director
affiliation: Merz Pharmaceutical, LLC
facility: 
facility: 
facility: 
facility: 
country: Dominican Republic
country: Honduras
country: United States
responsible party type: Sponsor
mesh term: Tinea
mesh term: Tinea Pedis
mesh term: Tinea cruris
mesh term: Naftifine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 