<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/NCT02227290</url>
  </required_header>
  <id_info>
    <org_study_id>MUS90200_4024_1</org_study_id>
    <nct_id>NCT02227290</nct_id>
  </id_info>
  <brief_title>Pediatric Subjects With Tinea Corporis</brief_title>
  <official_title>A Phase 4, Double-Blind, Randomized, Vehicle-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis</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>
      The study is being done to see how well the study cream works when applied once a day to&#xD;
      affected area of child (where they have ringworm). The results will be compared to those seen&#xD;
      with a placebo cream which has no active ingredient. Safety of the cream will also be&#xD;
      measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine&#xD;
      hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the&#xD;
      treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium&#xD;
      hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea&#xD;
      corporis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Efficacy</measure>
    <time_frame>Day 21</time_frame>
    <description>Complete cure defined by negative KOH result and negative dermatophyte culture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy</measure>
    <time_frame>Day 21</time_frame>
    <description>Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Success at Days 14 and 21</measure>
    <time_frame>Day 14 and Day 21</time_frame>
    <description>Defined as sign and symptom scores of 0 or 1</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical cure at Days 14 and 21</measure>
    <time_frame>Days 14 and 21</time_frame>
    <description>Defined as erythema, induration, and pruritus score of 0.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction</measure>
    <time_frame>Days 14 and 21</time_frame>
    <description>Assessment on 5 point scale or category of improvement from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Complete Cure</measure>
    <time_frame>Day 14</time_frame>
    <description>Defined as negative mycology and abscence of signs/symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment of Effectiveness</measure>
    <time_frame>Day 14</time_frame>
    <description>Defined as negative KOH, negative culture, and signs/symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mycology Cure</measure>
    <time_frame>Day 14</time_frame>
    <description>Defined as negative KOH result and negative dermatophyte culture.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Tinea Corporis</condition>
  <arm_group>
    <arm_group_label>Naftin Cream, 2%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once Daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Cream</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Once Daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naftin Cream</intervention_name>
    <arm_group_label>Naftin Cream, 2%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Cream</intervention_name>
    <arm_group_label>Placebo Cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or non-pregnant females 2 years of age to 17 years, 11 months, of any race.&#xD;
             Females of child bearing potential must have a negative urine pregnancy test.&#xD;
&#xD;
          -  Presence of tinea corporis by clinical evidence of a tinea infection of at least&#xD;
             moderate erythema, moderate induration, and mild pruritus.&#xD;
&#xD;
          -  KOH positive and culture positive baseline skin scrapings obtained form the site with&#xD;
             the mose severely affected lesion or a representative site of the overall severity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tinea infection of the face, scalp, groin, and/or feet&#xD;
&#xD;
          -  A life-threatening condition in the opinion of the investigator (ex. autoimmune&#xD;
             deficiency syndrome, cancer, etc) within the last 6 months.&#xD;
&#xD;
          -  Subjects with abnormal findings- physical or laboratory- that are considered by the&#xD;
             investigator to be clinically important and indicative of conditions that might&#xD;
             complicate interpretation of study results&#xD;
&#xD;
          -  Subjects with a known hypersensitivity or other contradictions to study medications or&#xD;
             their components.&#xD;
&#xD;
          -  Subjects who have a recent history or who are currently known to abuse alcohol or&#xD;
             drugs.&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus.&#xD;
&#xD;
          -  Hemodialysis or chronic ambulatory peritoneal dialysis therapy.&#xD;
&#xD;
          -  Current diagnosis of immunocompromising conditions.&#xD;
&#xD;
          -  Current evidence of compromised skin, atopic or contact dermatitis, eczema, impetigo,&#xD;
             lichen planus, pityriasis rosea, pityriasis versicolor, psoriasis, seborrhoeic&#xD;
             dermatitis and syphilis.&#xD;
&#xD;
          -  Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection&#xD;
&#xD;
          -  Patients with tinea corporis who have concurrent dermatophytosis of the scalp, beard&#xD;
             or nails.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Fleischer, MD</last_name>
    <role>Study Director</role>
    <affiliation>Merz North America, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Merz Investigative Site#001316</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site# 0010320</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001313</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001301</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001312</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001311</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site #001310</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001307</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001309</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001314</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001126</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001293</name>
      <address>
        <city>Winston Salem</city>
        <state>North Carolina</state>
        <zip>27104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site# 0010319</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001097</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#180002</name>
      <address>
        <city>San Cristobal</city>
        <country>Dominican Republic</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>
    <facility>
      <name>Merz Investigative Site#507001</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site#001279</name>
      <address>
        <city>Cidra</city>
        <zip>00739</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Dominican Republic</country>
    <country>Honduras</country>
    <country>Panama</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <disposition_first_submitted>October 6, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>October 6, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 7, 2016</disposition_first_posted>
  <last_update_submitted>October 27, 2016</last_update_submitted>
  <last_update_submitted_qc>October 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tinea Corporis</keyword>
  <keyword>Ringworm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinea</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02227290
org study id: MUS90200_4024_1
nct id: NCT02227290
lead sponsor: 
has dmc: No
The study is being done to see how well the study cream works when applied once a day to
      affected area of child (where they have ringworm). The results will be compared to those seen
      with a placebo cream which has no active ingredient. Safety of the cream will also be
      measured.
The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine
      hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the
      treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium
      hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea
      corporis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Primary Efficacy
time frame: Day 21
description: Complete cure defined by negative KOH result and negative dermatophyte culture
measure: Secondary Efficacy
time frame: Day 21
description: Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.
measure: Clinical Success at Days 14 and 21
time frame: Day 14 and Day 21
description: Defined as sign and symptom scores of 0 or 1
measure: Clinical cure at Days 14 and 21
time frame: Days 14 and 21
description: Defined as erythema, induration, and pruritus score of 0.
measure: Subject Satisfaction
time frame: Days 14 and 21
description: Assessment on 5 point scale or category of improvement from baseline.
measure: Complete Cure
time frame: Day 14
description: Defined as negative mycology and abscence of signs/symptoms.
measure: Treatment of Effectiveness
time frame: Day 14
description: Defined as negative KOH, negative culture, and signs/symptoms.
measure: Mycology Cure
time frame: Day 14
description: Defined as negative KOH result and negative dermatophyte culture.
arm group label: Naftin Cream, 2%
arm group type: Experimental
description: Once Daily
arm group label: Placebo Cream
arm group type: Placebo Comparator
description: Once Daily
intervention type: Drug
intervention name: Naftin Cream
arm group label: Naftin Cream, 2%
intervention type: Drug
intervention name: Placebo Cream
arm group label: Placebo Cream
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alan Fleischer, MD
role: Study Director
affiliation: Merz North America, Inc.
facility: 
facility: 
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country: Dominican Republic
country: Honduras
country: Panama
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Tinea