Back to results

Gene Expression and Biomarker Profiling of Keloid Skin

Primary Purpose

Keloid, Keloid of Ear Lobe, Healthy Adults

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Biopsy and/or triamcinolone injection

Excisional Biopsy

About this trial

This is an interventional other trial for Keloid focused on measuring Keloid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Northwestern University Feinberg School of Medicine Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Other

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Earlobe Keloid

Arm 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.

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

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

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.

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

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

Outcomes

Primary Outcome Measures

Keloid progression

Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)

Gene Expression

Blood will be drawn during first study visit for analysis

Keloid recurrence

Assess keloid recurrence at biopsy site (measured by number of keloids)

Secondary Outcome Measures

Full Information

NCT ID

NCT03228693

First Posted

July 20, 2017

Last Updated

March 28, 2023

Sponsor

Northwestern University

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03228693

Brief Title

Gene Expression and Biomarker Profiling of Keloid Skin

Official Title

Gene Expression and Biomarker Profiling of Keloid Skin

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

September 11, 2017 (Actual)

Primary Completion Date

September 2, 2021 (Actual)

Study Completion Date

January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study aims to examine both the genetic profile and the biomarkers implicated in keloid scar formation. Hypothesis: Differences in the genetic profiles of lesional and non-lesional skin contribute a given population's propensity to develop keloids Differences in biomolecules expressed in subjects with and without keloids can help predict keloid occurrence and severity Biomarker analysis will provide useful insights for future targeted therapies for keloid scars

Detailed Description

Objectives: Determine gene expression profiles of keloid scar tissue using samples collected longitudinally Define and compare the molecular biomarkers of keloid scars in keloid (lesional) and non-lesional skin biopsies and serum samples from adult subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keloid, Keloid of Ear Lobe, Healthy Adults

Keywords

Keloid

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Active Comparator

Arm 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.

Arm Title

Group 2

Arm Type

Active Comparator

Arm 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

Arm Title

Group 3

Arm Type

Active Comparator

Arm 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.

Arm Title

Group 4

Arm Type

Active Comparator

Arm 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.

Arm Title

Group 5

Arm Type

Active Comparator

Arm Description

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

Arm Title

Earlobe Keloid

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Biopsy and/or triamcinolone injection

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Excisional Biopsy

Intervention Description

Complete excision of an earlobe keloid will be taken.

Primary Outcome Measure Information:

Title

Keloid progression

Description

Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)

Time Frame

One year

Title

Gene Expression

Description

Blood will be drawn during first study visit for analysis

Time Frame

One year

Title

Keloid recurrence

Description

Assess keloid recurrence at biopsy site (measured by number of keloids)

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roopal Kundu, M.D.

Organizational Affiliation

Northwestern University Feinberg School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine Department of Dermatology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Gene Expression and Biomarker Profiling of Keloid Skin

We'll reach out to this number within 24 hrs