Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2017-09-11
2023-01-31
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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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.
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.
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
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.
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.
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.
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.
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.
Group 5
Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids.
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.
Earlobe Keloid
Complete excision of an earlobe keloid measuring \> 10mm will be taken.
Excisional Biopsy
Complete excision of an earlobe keloid will be taken.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients without keloids coming into the dermatology clinic for a keloid unrelated issue (Group 5 only)
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Roopal Kundu
Associate Professor of Dermatology and Medical Education
Principal Investigators
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Roopal Kundu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Northwestern University Feinberg School of Medicine
Locations
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Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, United States
Countries
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Other Identifiers
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RVK 09062016
Identifier Type: -
Identifier Source: org_study_id
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