Status:
COMPLETED
Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
Lead Sponsor:
NYU Langone Health
Conditions:
Keloid Scar
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief Summary
This is a split-scar study with a target sample size of 20. There are two interventions: fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and fractional erbium:YAG-assisted drug delivery...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 18-89
- Has one large keloid scar or at least two similar but separate keloid scars
- Keloid present for at least 1 year
- Exclusion Criteria
- Currently pregnant
- Currently breastfeeding
- Have taken oral retinoids within 6 months of study initiation
- Has had keloid treatment within 1 month of study initiation
- Has active infection at treatment site
- Has active malignancy
- Presence of pedunculated keloid(s) or keloid(s) that are judged to be best treated with surgical excision first
- Hypertrophic scars
- Known hypersensitivity to TAC or 5-FU
- Chronic systemic corticosteroid or immunosuppressive medication use
- Has intolerance to anesthesia
- Has known connective tissue disease
- Has known infectious disease
Exclusion
Key Trial Info
Start Date :
January 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04786210
Start Date
January 30 2021
End Date
December 16 2022
Last Update
March 26 2024
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016