Gene Expression and Biomarker Profiling of Keloid Skin

• Sponsor: Northwestern University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03228693
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 130
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 59.7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Keloid; Keloid of Ear Lobe; Healthy Adults	Procedure: Biopsy and/or triamcinolone injection; Procedure: Excisional Biopsy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Gene Expression and Biomarker Profiling of Keloid Skin
• Actual Study Start Date: Sep 11, 2017
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 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.	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.
Active Comparator: Group 2 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	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.
Active Comparator: Group 3 Baseline lesional and non-lesional biopsy and re-biopsy 3-4 months later with intralesional triamcinolone injections at 18-20 and 24-32 weeks.	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.
Active Comparator: Group 4 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.	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.
Active Comparator: Group 5 Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids.	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.
Other: Earlobe Keloid Complete excision of an earlobe keloid measuring > 10mm will be taken.	Procedure: Excisional Biopsy; Complete excision of an earlobe keloid will be taken.

Outcome Measures

Primary Outcome Measures

1. Keloid progression [One year]

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

2. Gene Expression [One year]

   Blood will be drawn during first study visit for analysis

3. Keloid recurrence [One year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• Regeneron Pharmaceuticals

Investigators

• Principal Investigator: Roopal Kundu, M.D., Northwestern University Feinberg School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roopal Kundu, Associate Professor of Dermatology and Medical Education, Northwestern University
• ClinicalTrials.gov Identifier: NCT03228693
• Other Study ID Numbers: RVK 09062016
• First Posted: Jul 25, 2017
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Roopal Kundu, Associate Professor of Dermatology and Medical Education, Northwestern University: Keloid
• Additional relevant MeSH terms: Keloid; Triamcinolone

Study Results

No Results Posted as of May 9, 2022