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CompletedNCT03228693Updated Mar 29, 2023

Gene Expression and Biomarker Profiling of Keloid Skin

An interventional study of Biopsy and/or triamcinolone injection and Excisional Biopsy in Keloid, Keloid of Ear Lobe and Healthy Adults, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Northwestern University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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
02

Conditions studied

  • Keloid
  • Keloid of Ear Lobe
  • Healthy Adults

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Keywords

  • Keloid
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Patients who have had treatment of their keloid scar within 6 months of date of enrollment
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • Other
    Earlobe Keloid

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

    Procedure: Excisional Biopsy

Interventions

  • ProcedureBiopsy 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.

  • ProcedureExcisional Biopsy

    Complete excision of an earlobe keloid will be taken.

05

What researchers measure

Primary outcomes

  1. Keloid progression

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

    Time frame: One year

  2. Gene Expression

    Blood will be drawn during first study visit for analysis

    Time frame: One year

  3. Keloid recurrence

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

    Time frame: One year

06

Study locations

1 site
  • Northwestern University Feinberg School of Medicine Department of Dermatology
    Chicago, Illinois 60611, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03228693
Lead sponsor
Northwestern University
Collaborators
Regeneron Pharmaceuticals
Responsible party
Roopal Kundu (Associate Professor of Dermatology and Medical Education, Northwestern University) — Principal investigator
First posted
Jul 25, 2017
Start date
Sep 11, 2017
Primary completion
Sep 2, 2021
Completion
Jan 31, 2023
Last update
Mar 29, 2023

Study contacts

Roopal Kundu, M.D.
principal investigator · Northwestern University Feinberg School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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