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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Healthy Adults
• Keloid
• Keloid of Ear Lobe

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