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NCT03228693 Clinical Trial

Gene Expression and Biomarker Profiling of Keloid Skin

Healthy Adults Clinical Trial

Official title:
Gene Expression and Biomarker Profiling of Keloid Skin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03228693
Other study ID # RVK 09062016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 11, 2017
Est. completion date January 31, 2023

Study information
Verified date March 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date January 31, 2023
Est. primary completion date September 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• Excisional Biopsy
Complete excision of an earlobe keloid will be taken.

Locations
Country Name City State
United States Northwestern University Feinberg School of Medicine Department of Dermatology Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Northwestern University Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

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