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OpenTrials
Completed

NCT Number: NCT03228693

Gene Expression and Biomarker Profiling of Keloid Skin

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

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Key information

Conditions

Keloid Cicatrix Collagen Diseases Connective Tissue Diseases Fibrosis Healthy Adults Keloid of Ear Lobe Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy and/or triamcinolone injection

Procedure

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

Procedure

Complete excision of an earlobe keloid will be taken.

Primary outcomes

  1. Keloid progression

    Time frame: One year

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

  2. Gene Expression

    Time frame: One year

    Blood will be drawn during first study visit for analysis

  3. Keloid recurrence

    Time frame: One year

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2023
First posted
Jul 25, 2017
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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