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Earlobe Keloid for Keloid
N/A
Waitlist Available
Led By Roopal Kundu, M.D.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial will compare the genetic profiles and biomarkers of people with and without keloids to see if there are differences that could help predict and treat keloids.
Eligible Conditions
- Keloid of Ear Lobe
- Keloid
- Healthy Adults
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gene Expression
Keloid progression
Keloid recurrence
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Earlobe KeloidExperimental Treatment1 Intervention
Complete excision of an earlobe keloid measuring > 10mm will be taken.
Group II: Group 2Active Control1 Intervention
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
Group III: Group 1Active Control1 Intervention
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.
Group IV: Group 3Active Control1 Intervention
Baseline lesional and non-lesional biopsy and re-biopsy 3-4 months later with intralesional triamcinolone injections at 18-20 and 24-32 weeks.
Group V: Group 5Active Control1 Intervention
Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids.
Group VI: Group 4Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Excisional Biopsy
2017
N/A
~50
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,576 Previous Clinical Trials
911,904 Total Patients Enrolled
1 Trials studying Keloid
40 Patients Enrolled for Keloid
Regeneron PharmaceuticalsIndustry Sponsor
613 Previous Clinical Trials
379,411 Total Patients Enrolled
2 Trials studying Keloid
64 Patients Enrolled for Keloid
Roopal Kundu, M.D.Principal InvestigatorNorthwestern University Feinberg School of Medicine
1 Previous Clinical Trials
31 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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