<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/NCT01712295</url>
  </required_header>
  <id_info>
    <org_study_id>R12-3128</org_study_id>
    <nct_id>NCT01712295</nct_id>
  </id_info>
  <brief_title>17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts</brief_title>
  <official_title>New Formulation of Salicylate to Improve Treatment of Common Skin Warts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grossman, Michael, D.P.M.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Main Line Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Grossman, Michael, D.P.M.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Plantar warts on the sole of the foot are among the most common warts seen in podiatry&#xD;
      clinics. Some patients are readily cured by simple standard of care treatments that include&#xD;
      wart debridement (trimming or excision) and application of 17% salicylate (commercially known&#xD;
      as Compound W)or by other treatments that may be painful and affect mobility. No treatment is&#xD;
      consistently effective and most patients fail treatment multiple times.&#xD;
&#xD;
      Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that&#xD;
      may improve the activity of salicylate in wart treatment by improving the ability to&#xD;
      penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may&#xD;
      improve cures of common foot plantar warts in subjects who also be receiving other&#xD;
      standard-of-care treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2011</start_date>
  <completion_date type="Anticipated">March 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.</measure>
    <time_frame>16 weeks</time_frame>
    <description>Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine if salicylate with ethyl pyruvate (SA-EP) in treatment of plantar warts causes adverse events other than those known to occur with SA (salicylate)alone.</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Warts</condition>
  <arm_group>
    <arm_group_label>17% Salicylate with Ethyl Pyruvate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>17% salicylate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>subjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>17% Salicylate with ethyl pyruvate</intervention_name>
    <arm_group_label>17% Salicylate with Ethyl Pyruvate</arm_group_label>
    <other_name>Compound W</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salicylates</intervention_name>
    <arm_group_label>17% salicylate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  evidence of skin plantar wart(s)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  iodine allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael R Grossman, DPM</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_contact>
    <last_name>Michael Grossman, DPM</last_name>
    <phone>610-645-6314</phone>
    <email>michaelrgrossman@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Main Line Foot and Ankle Center</name>
      <address>
        <city>Ardmore</city>
        <state>Pennsylvania</state>
        <zip>19003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael R Grossman, DPM</last_name>
      <phone>610-645-6314</phone>
      <email>michaelrgrossman@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Michael R Grossman, DPM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 22, 2012</last_update_submitted>
  <last_update_submitted_qc>October 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Warts</keyword>
  <keyword>salicylic acid</keyword>
  <keyword>ethyl pyruvate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warts</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salicylic Acid</mesh_term>
    <mesh_term>Salicylates</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01712295
org study id: R12-3128
nct id: NCT01712295
lead sponsor: 
collaborator: 
has dmc: No
Plantar warts on the sole of the foot are among the most common warts seen in podiatry
      clinics. Some patients are readily cured by simple standard of care treatments that include
      wart debridement (trimming or excision) and application of 17% salicylate (commercially known
      as Compound W)or by other treatments that may be painful and affect mobility. No treatment is
      consistently effective and most patients fail treatment multiple times.

      Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that
      may improve the activity of salicylate in wart treatment by improving the ability to
      penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may
      improve cures of common foot plantar warts in subjects who also be receiving other
      standard-of-care treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.
time frame: 16 weeks
description: Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks.
measure: To determine if salicylate with ethyl pyruvate (SA-EP) in treatment of plantar warts causes adverse events other than those known to occur with SA (salicylate)alone.
time frame: 16 weeks
arm group label: 17% Salicylate with Ethyl Pyruvate
arm group type: Experimental
description: Subjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks.
arm group label: 17% salicylate
arm group type: Active Comparator
description: subjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks
intervention type: Drug
intervention name: 17% Salicylate with ethyl pyruvate
arm group label: 17% Salicylate with Ethyl Pyruvate
other name: Compound W
intervention type: Drug
intervention name: Salicylates
arm group label: 17% salicylate
criteria: 
gender: All
minimum age: 12 Years
maximum age: 75 Years
healthy volunteers: No
last name: Michael R Grossman, DPM
role: Principal Investigator
last name: Michael Grossman, DPM
phone: 610-645-6314
email: michaelrgrossman@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Warts
mesh term: Salicylic Acid
mesh term: Salicylates