Gene Expression and Biomarker Profiling of Keloid Skin

Northwestern University

Status: Completed

Conditions: Keloid; Healthy Adults; Keloid of Ear Lobe

Treatments: Procedure: Excisional Biopsy; Procedure: Biopsy and/or triamcinolone injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03228693

RVK 09062016

Details and patient eligibility

About

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

Full 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

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 6 patient groups

Group 1

Active Comparator group

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.

Treatment:

Procedure: Biopsy and/or triamcinolone injection

Group 2

Active Comparator group

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

Treatment:

Procedure: Biopsy and/or triamcinolone injection

Group 3

Active Comparator group

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.

Treatment:

Procedure: Biopsy and/or triamcinolone injection

Group 4

Active Comparator group

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.

Treatment:

Procedure: Biopsy and/or triamcinolone injection

Group 5

Active Comparator group

Description:

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

Treatment:

Procedure: Biopsy and/or triamcinolone injection

Earlobe Keloid

Other group

Description:

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

Treatment:

Procedure: Excisional Biopsy