<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/NCT01696799</url>
  </required_header>
  <id_info>
    <org_study_id>079-2951-109</org_study_id>
    <nct_id>NCT01696799</nct_id>
  </id_info>
  <brief_title>Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years</brief_title>
  <official_title>A Multi-Center, Randomized Comparative Study of the Pharmacokinetics of Econazole Nitrate 1% Foam and Econazole Nitrate 1% Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AmDerma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AmDerma Pharmaceuticals, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AmDerma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in&#xD;
      subjects with interdigital tinea pedis aged 12 years to less than 18 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on the results of a previous clinical study evaluating the pharmacokinetics, safety and&#xD;
      efficacy of EN Foam versus the reference listed econazole nitrate cream and the foam vehicle&#xD;
      in adults, the current clinical study is being conducted to provide additional&#xD;
      pharmacokinetic data for EN in the foam formulation in subjects ages 12 to less than 18 years&#xD;
      with interdigital tinea pedis to support a clinical bridge for systemic safety to the RLD in&#xD;
      this pediatric population. The study also includes clinical and safety endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma Levels of Econazole Nitrate</measure>
    <time_frame>28 Days</time_frame>
    <description>Blood will be taken at Baseline (Day 1) prior to the application of medication, and at the end of treatment (Day 28), just prior to the last dose of medication, and at 7 (±1 hr) hours post-drug application and a third blood draw 4 (±1 hr) hours after the second PK blood draw.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator Assessment of Response to Treatment</measure>
    <time_frame>28 Days</time_frame>
    <description>At the end of treatment (Day 28), the Investigator will assess the subject's response to treatment using a 5-point scale (1 = excellent, 2 = very good, 3 = good, 4 = fair, and 5 = poor).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dosing Compliance</measure>
    <time_frame>28 Days</time_frame>
    <description>Measures of study medication compliance will include the total number of applications, duration of treatment, and the total amount of study medication used. The amount of study medication used will be determined post-study following thereturn of all clinical supplies.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Interdigital Tinea Pedis</condition>
  <arm_group>
    <arm_group_label>Econazole Nitrate Foam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Investigational Drug Product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Foam</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle Foam Comparator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Econazole Nitrate Cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active comparator cream product</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Econazole Nitrate</intervention_name>
    <arm_group_label>Econazole Nitrate Cream</arm_group_label>
    <arm_group_label>Econazole Nitrate Foam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Vehicle Foam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be between 12 years and less than 18 years of age and of either sex.&#xD;
&#xD;
          -  Have a clinical diagnosis of interdigital tinea pedis&#xD;
&#xD;
          -  Parent/guardian has provided written informed consent and the subject has provided&#xD;
             written assent.&#xD;
&#xD;
          -  Be willing and able to use the assigned study medication as directed and to commit to&#xD;
             all follow-up visits for the duration of the study.&#xD;
&#xD;
          -  Have microscopic evidence (positive KOH) of the presence of fungi and a positive&#xD;
             fungal culture.&#xD;
&#xD;
          -  Be in good health and free of any disease or physical condition which might, in the&#xD;
             Investigator's opinion, expose the subject to an unacceptable risk by study&#xD;
             participation.&#xD;
&#xD;
          -  Females must be non-pregnant, non-lactating and not intending to become pregnant&#xD;
             during the course of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is pregnant, nursing or planning a pregnancy during the study&#xD;
&#xD;
          -  Has used topical antifungals or topical corticosteroids on the feet within 14 days&#xD;
             prior to the start of the study.&#xD;
&#xD;
          -  Has received systemic antifungal therapy within 12 weeks prior to the start of the&#xD;
             study medication.&#xD;
&#xD;
          -  Has used systemic antibacterials or systemic corticosteroids within 14 days prior to&#xD;
             the start of the study.&#xD;
&#xD;
          -  Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to&#xD;
             disease, e.g., HIV, or medications).&#xD;
&#xD;
          -  Has concurrent moccasin-type tinea pedis (in the opinion of the Investigator).&#xD;
&#xD;
          -  Has any other skin disease which might interfere with the evaluation of tinea pedis.&#xD;
&#xD;
          -  Is currently enrolled in an investigational drug or device study.&#xD;
&#xD;
          -  Has received an investigational drug or treatment with an investigational device&#xD;
             within 30 days prior to entering this study.&#xD;
&#xD;
          -  Is unreliable, including subjects with a history of drug or alcohol abuse.&#xD;
&#xD;
          -  Has known hypersensitivity to any of the components of the study medications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Therapeutics Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>September 28, 2012</last_update_submitted>
  <last_update_submitted_qc>September 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2012</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>Tinea</mesh_term>
    <mesh_term>Tinea Pedis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Econazole</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>December 5, 2012</submitted>
    <returned>January 9, 2013</returned>
    <submitted>January 9, 2013</submitted>
    <returned>February 11, 2013</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01696799
org study id: 079-2951-109
nct id: NCT01696799
lead sponsor: 
collaborator: 
has dmc: No
To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in
      subjects with interdigital tinea pedis aged 12 years to less than 18 years.
Based on the results of a previous clinical study evaluating the pharmacokinetics, safety and
      efficacy of EN Foam versus the reference listed econazole nitrate cream and the foam vehicle
      in adults, the current clinical study is being conducted to provide additional
      pharmacokinetic data for EN in the foam formulation in subjects ages 12 to less than 18 years
      with interdigital tinea pedis to support a clinical bridge for systemic safety to the RLD in
      this pediatric population. The study also includes clinical and safety endpoints.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Plasma Levels of Econazole Nitrate
time frame: 28 Days
description: Blood will be taken at Baseline (Day 1) prior to the application of medication, and at the end of treatment (Day 28), just prior to the last dose of medication, and at 7 (±1 hr) hours post-drug application and a third blood draw 4 (±1 hr) hours after the second PK blood draw.
measure: Investigator Assessment of Response to Treatment
time frame: 28 Days
description: At the end of treatment (Day 28), the Investigator will assess the subject's response to treatment using a 5-point scale (1 = excellent, 2 = very good, 3 = good, 4 = fair, and 5 = poor).
measure: Dosing Compliance
time frame: 28 Days
description: Measures of study medication compliance will include the total number of applications, duration of treatment, and the total amount of study medication used. The amount of study medication used will be determined post-study following thereturn of all clinical supplies.
arm group label: Econazole Nitrate Foam
arm group type: Experimental
description: Investigational Drug Product
arm group label: Vehicle Foam
arm group type: Placebo Comparator
description: Vehicle Foam Comparator
arm group label: Econazole Nitrate Cream
arm group type: Active Comparator
description: Active comparator cream product
intervention type: Drug
intervention name: Econazole Nitrate
arm group label: Econazole Nitrate Cream
arm group label: Econazole Nitrate Foam
intervention type: Drug
intervention name: placebo
arm group label: Vehicle Foam
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tinea
mesh term: Tinea Pedis
mesh term: Econazole
submitted: December 5, 2012
returned: January 9, 2013
submitted: January 9, 2013
returned: February 11, 2013