Gene Expression and Biomarker Profiling of Keloid Skin

March 28, 2023 updated by: Roopal Kundu, Northwestern University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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
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.
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.
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.
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.
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.
Active Comparator: Group 5
Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids.
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.
Other: Earlobe Keloid
Complete excision of an earlobe keloid measuring > 10mm will be taken.
Procedure: Excisional Biopsy
Complete excision of an earlobe keloid will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keloid progression
Time Frame: One year
Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)
One year
Gene Expression
Time Frame: One year
Blood will be drawn during first study visit for analysis
One year
Keloid recurrence
Time Frame: One year
Assess keloid recurrence at biopsy site (measured by number of keloids)
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Principal Investigator: Roopal Kundu, M.D., Northwestern University Feinberg School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2017

Primary Completion (Actual)

September 2, 2021

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

July 20, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (Actual)

July 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVK 09062016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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