Completed

Gene Expression and Biomarker Profiling of Keloid Skin

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What is being tested

Biopsy and/or triamcinolone injection

+ Excisional Biopsy

Procedure
Who is being recruted

Cicatrix+5

+ Collagen Diseases

+ Connective Tissue Diseases

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: September 2017
See protocol details

Summary

Principal SponsorNorthwestern University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 11, 2017

Actual date on which the first participant was enrolled.

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

Official TitleGene Expression and Biomarker Profiling of Keloid Skin
NCT03228693
Principal SponsorNorthwestern University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CicatrixCollagen DiseasesConnective Tissue DiseasesFibrosisKeloidPathologic ProcessesPathological Conditions, Signs and SymptomsSkin and Connective Tissue Diseases

Criteria

2 inclusion criteria required to participate
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)
1 exclusion criteria prevent from participating
Patients who have had treatment of their keloid scar within 6 months of date of enrollment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

Active Comparator
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

Group III

Active Comparator
Baseline lesional and non-lesional biopsy and re-biopsy 3-4 months later with intralesional triamcinolone injections at 18-20 and 24-32 weeks.

Group IV

Active Comparator
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.

Group 5

Active Comparator
Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids.

Group 6

Complete excision of an earlobe keloid measuring \> 10mm will be taken.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, United StatesOpen Northwestern University Feinberg School of Medicine Department of Dermatology in Google Maps
CompletedOne Study Center