<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/NCT03228693</url>
  </required_header>
  <id_info>
    <org_study_id>RVK 09062016</org_study_id>
    <nct_id>NCT03228693</nct_id>
  </id_info>
  <brief_title>Gene Expression and Biomarker Profiling of Keloid Skin</brief_title>
  <official_title>Gene Expression and Biomarker Profiling of Keloid Skin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to examine both the genetic profile and the biomarkers implicated in keloid&#xD;
      scar formation.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
        1. Differences in the genetic profiles of lesional and non-lesional skin contribute a given&#xD;
           population's propensity to develop keloids&#xD;
&#xD;
        2. Differences in biomolecules expressed in subjects with and without keloids can help&#xD;
           predict keloid occurrence and severity&#xD;
&#xD;
        3. Biomarker analysis will provide useful insights for future targeted therapies for keloid&#xD;
           scars&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
        1. Determine gene expression profiles of keloid scar tissue using samples collected&#xD;
           longitudinally&#xD;
&#xD;
        2. Define and compare the molecular biomarkers of keloid scars in keloid (lesional) and&#xD;
           non-lesional skin biopsies and serum samples from adult subjects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">January 31, 2023</completion_date>
  <primary_completion_date type="Actual">September 2, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Keloid progression</measure>
    <time_frame>One year</time_frame>
    <description>Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gene Expression</measure>
    <time_frame>One year</time_frame>
    <description>Blood will be drawn during first study visit for analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Keloid recurrence</measure>
    <time_frame>One year</time_frame>
    <description>Assess keloid recurrence at biopsy site (measured by number of keloids)</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Keloid</condition>
  <condition>Keloid of Ear Lobe</condition>
  <condition>Healthy Adults</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Baseline lesional and non-lesional biopsies and re-biopsy 6-8 weeks later with intralesional triamcinolone injections at 9-10, 12-16, and 24-32 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Baseline lesional biopsy and re-biopsy at 6-8 weeks with intralesional triamcinolone injections at 3-4, 9-10, 12-16, and 24-32 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Baseline lesional and non-lesional biopsy and re-biopsy 3-4 months later with intralesional triamcinolone injections at 18-20 and 24-32 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Baseline lesional biopsy and re-biopsy at 3-4 months with intralesional triamcinolone injections at 3-4, 6-8, 18-20 and 24-32 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Earlobe Keloid</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Complete excision of an earlobe keloid measuring &gt; 10mm will be taken.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biopsy and/or triamcinolone injection</intervention_name>
    <description>Subjects will have their blood drawn during the first study visit. Subsequently, a punch biopsy and/or triamcinolone injection will be given based on group timeline.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_label>Group 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Excisional Biopsy</intervention_name>
    <description>Complete excision of an earlobe keloid will be taken.</description>
    <arm_group_label>Earlobe Keloid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with an untreated keloid scar or a patient with a keloid scar that has not had&#xD;
             treatment for at least 6 months before time of enrollment&#xD;
&#xD;
          -  Patients without keloids coming into the dermatology clinic for a keloid unrelated&#xD;
             issue (Group 5 only)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had treatment of their keloid scar within 6 months of date of&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roopal Kundu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University Feinberg School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Roopal Kundu</investigator_full_name>
    <investigator_title>Associate Professor of Dermatology and Medical Education</investigator_title>
  </responsible_party>
  <keyword>Keloid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keloid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03228693
org study id: RVK 09062016
nct id: NCT03228693
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aims to examine both the genetic profile and the biomarkers implicated in keloid
      scar formation.

      Hypothesis:

        1. Differences in the genetic profiles of lesional and non-lesional skin contribute a given
           population's propensity to develop keloids

        2. Differences in biomolecules expressed in subjects with and without keloids can help
           predict keloid occurrence and severity

        3. Biomarker analysis will provide useful insights for future targeted therapies for keloid
           scars
Objectives:

        1. Determine gene expression profiles of keloid scar tissue using samples collected
           longitudinally

        2. Define and compare the molecular biomarkers of keloid scars in keloid (lesional) and
           non-lesional skin biopsies and serum samples from adult subjects
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: None (Open Label)
measure: Keloid progression
time frame: One year
description: Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)
measure: Gene Expression
time frame: One year
description: Blood will be drawn during first study visit for analysis
measure: Keloid recurrence
time frame: One year
description: Assess keloid recurrence at biopsy site (measured by number of keloids)
arm group label: Group 1
arm group type: Active Comparator
description: Baseline lesional and non-lesional biopsies and re-biopsy 6-8 weeks later with intralesional triamcinolone injections at 9-10, 12-16, and 24-32 weeks.
arm group label: Group 2
arm group type: Active Comparator
description: Baseline lesional biopsy and re-biopsy at 6-8 weeks with intralesional triamcinolone injections at 3-4, 9-10, 12-16, and 24-32 weeks
arm group label: Group 3
arm group type: Active Comparator
description: Baseline lesional and non-lesional biopsy and re-biopsy 3-4 months later with intralesional triamcinolone injections at 18-20 and 24-32 weeks.
arm group label: Group 4
arm group type: Active Comparator
description: Baseline lesional biopsy and re-biopsy at 3-4 months with intralesional triamcinolone injections at 3-4, 6-8, 18-20 and 24-32 weeks.
arm group label: Group 5
arm group type: Active Comparator
description: Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids.
arm group label: Earlobe Keloid
arm group type: Other
description: Complete excision of an earlobe keloid measuring > 10mm will be taken.
intervention type: Procedure
intervention name: Biopsy and/or triamcinolone injection
description: Subjects will have their blood drawn during the first study visit. Subsequently, a punch biopsy and/or triamcinolone injection will be given based on group timeline.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
arm group label: Group 5
intervention type: Procedure
intervention name: Excisional Biopsy
description: Complete excision of an earlobe keloid will be taken.
arm group label: Earlobe Keloid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Roopal Kundu, M.D.
role: Principal Investigator
affiliation: Northwestern University Feinberg School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Roopal Kundu
investigator title: Associate Professor of Dermatology and Medical Education
mesh term: Keloid
mesh term: Triamcinolone
sharing ipd: Undecided