Gene Expression and Biomarker Profiling of Keloid Skin

Not Applicable

Completed

• Conditions: Keloid; Keloid of Ear Lobe; Healthy Adults
• Interventions: Procedure: Biopsy and/or triamcinolone injection; Procedure: Excisional Biopsy

• Registration Number: NCT03228693
• Lead Sponsor: Northwestern University

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 Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-25
• Study Start: 2017-09-11
• Primary Completion: 2021-09-02
• Study Completion: 2023-01-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Read More

Exclusion Criteria

• Patients who have had treatment of their keloid scar within 6 months of date of enrollment

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 2	Biopsy and/or triamcinolone injection	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 3	Biopsy and/or triamcinolone injection	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 4	Biopsy and/or triamcinolone injection	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	Biopsy and/or triamcinolone injection	Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids.
Earlobe Keloid	Excisional Biopsy	Complete excision of an earlobe keloid measuring \> 10mm will be taken.
Group 1	Biopsy and/or triamcinolone injection	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine Department of Dermatology; 🇺🇸 Chicago, Illinois, United States