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Gene Expression and Biomarker Profiling of Keloid Skin

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ClinicalTrials.gov Identifier: NCT03228693
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Roopal Kundu, Northwestern University

Tracking Information
First Submitted Date  ICMJE July 20, 2017
First Posted Date  ICMJE July 25, 2017
Last Update Posted Date February 18, 2019
Actual Study Start Date  ICMJE September 11, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
  • Keloid progression [ Time Frame: One year ]
    Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)
  • Gene Expression [ Time Frame: One year ]
    Blood will be drawn during first study visit for analysis
  • Keloid recurrence [ Time Frame: One year ]
    Assess keloid recurrence at biopsy site (measured by number of keloids)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03228693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gene Expression and Biomarker Profiling of Keloid Skin
Official Title  ICMJE Gene Expression and Biomarker Profiling of Keloid Skin
Brief Summary

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
Detailed Description

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Keloid
  • Keloid of Ear Lobe
  • Healthy Adults
Intervention  ICMJE
  • Procedure: Biopsy and/or triamcinolone injection
    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.
  • Procedure: Excisional Biopsy
    Complete excision of an earlobe keloid will be taken.
Study Arms  ICMJE
  • Active Comparator: Group 1
    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.
    Intervention: Procedure: Biopsy and/or triamcinolone injection
  • Active Comparator: Group 2
    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
    Intervention: Procedure: Biopsy and/or triamcinolone injection
  • Active Comparator: Group 3
    Baseline lesional and non-lesional biopsy and re-biopsy 3-4 months later with intralesional triamcinolone injections at 18-20 and 24-32 weeks.
    Intervention: Procedure: Biopsy and/or triamcinolone injection
  • Active Comparator: Group 4
    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.
    Intervention: Procedure: Biopsy and/or triamcinolone injection
  • Active Comparator: Group 5
    Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids.
    Intervention: Procedure: Biopsy and/or triamcinolone injection
  • Earlobe Keloid
    Complete excision of an earlobe keloid measuring > 10mm will be taken.
    Intervention: Procedure: Excisional Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2017)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with an untreated keloid scar or a patient with a keloid scar that has not had treatment for at least 6 months before time of enrollment
  • Patients without keloids coming into the dermatology clinic for a keloid unrelated issue (Group 5 only)

Exclusion Criteria:

  • Patients who have had treatment of their keloid scar within 6 months of date of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yasmeen Ali 3125035906 yasmeen.ali@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03228693
Other Study ID Numbers  ICMJE RVK 09062016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Roopal Kundu, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Roopal Kundu, M.D. Northwestern University Feinberg School of Medicine
PRS Account Northwestern University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP