<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/NCT01720056</url>
  </required_header>
  <id_info>
    <org_study_id>EC 067/2012</org_study_id>
    <nct_id>NCT01720056</nct_id>
  </id_info>
  <brief_title>Verapamil vs Steroid to Prevent Keloid Recurrence</brief_title>
  <official_title>Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Western Australia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Western Australia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard&#xD;
      treatment is yet to be clarified. This randomized clinical pilot study will compare the&#xD;
      effects of two local treatments for preventing keloid recurrence after surgical removal;&#xD;
      steroid and verapamil.&#xD;
&#xD;
      Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal&#xD;
      treatment efficacy as steroid injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Objective of study achieved after interim analysis.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Keloid recurrence</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vancouver Scar Scale Score</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Keloid Scars</condition>
  <arm_group>
    <arm_group_label>Verapamil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Verapamil 2.5 mg/mL injection sc intralesionally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kenalog 10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Kenalog 10 mg/mL injection sc intralesionally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Verapamil</intervention_name>
    <arm_group_label>Verapamil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kenalog 10</intervention_name>
    <arm_group_label>Kenalog 10</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient undergoing surgical removal of keloid&#xD;
&#xD;
          -  Patient 18 years old or greater&#xD;
&#xD;
          -  Length of excisional scar after surgical removal of keloid between 2 and 10 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Keloid in face or hands&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Any heart or pulmonary condition&#xD;
&#xD;
          -  Systemic treatment with beta-blockers, ACE-inhibitors or calcium antagonists&#xD;
&#xD;
          -  Systemic corticosteroidal therapy&#xD;
&#xD;
          -  Intralesional steroid treatment within 2 months of surgery to remove keloid&#xD;
&#xD;
          -  Flap surgery&#xD;
&#xD;
          -  Lesions to face, hands and other cosmetically sensitive areas&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fiona M Wood, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Western Australia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Perth Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6001</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>June 9, 2015</last_update_submitted>
  <last_update_submitted_qc>June 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Western Australia</investigator_affiliation>
    <investigator_full_name>Fiona M. Wood</investigator_full_name>
    <investigator_title>Prof. Wood</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keloid</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Verapamil</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/NCT01720056
org study id: EC 067/2012
nct id: NCT01720056
lead sponsor: 
has dmc: Yes
Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard
      treatment is yet to be clarified. This randomized clinical pilot study will compare the
      effects of two local treatments for preventing keloid recurrence after surgical removal;
      steroid and verapamil.

      Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal
      treatment efficacy as steroid injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Keloid recurrence
time frame: 1 year
measure: Vancouver Scar Scale Score
time frame: 1 year
arm group label: Verapamil
arm group type: Active Comparator
description: Verapamil 2.5 mg/mL injection sc intralesionally
arm group label: Kenalog 10
arm group type: Active Comparator
description: Kenalog 10 mg/mL injection sc intralesionally
intervention type: Drug
intervention name: Verapamil
arm group label: Verapamil
intervention type: Drug
intervention name: Kenalog 10
arm group label: Kenalog 10
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fiona M Wood, Professor
role: Principal Investigator
affiliation: The University of Western Australia
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: The University of Western Australia
investigator full name: Fiona M. Wood
investigator title: Prof. Wood
mesh term: Keloid
mesh term: Recurrence
mesh term: Triamcinolone Acetonide
mesh term: Verapamil