Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
NCT ID: NCT04786210
Last Updated: 2024-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2021-01-30
2022-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Site A of keloid scar
One half of keloid scarring on a single subject
Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil
Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments)
Site B of keloid scar
One half of keloid scarring on a single subject
Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
Split-scar fractional ablative erbium laser-assisted delivery of 10 mg/mL of triamcinolone acetonide solution to the other half of the scar (4 treatments)
Interventions
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Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil
Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments)
Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
Split-scar fractional ablative erbium laser-assisted delivery of 10 mg/mL of triamcinolone acetonide solution to the other half of the scar (4 treatments)
Eligibility Criteria
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Inclusion Criteria
2. Has one large keloid scar or at least two similar but separate keloid scars
3. Keloid present for at least 1 year
Exclusion Criteria
2. Currently breastfeeding
3. Have taken oral retinoids within 6 months of study initiation
4. Has had keloid treatment within 1 month of study initiation
5. Has active infection at treatment site
6. Has active malignancy
7. Presence of pedunculated keloid(s) or keloid(s) that are judged to be best treated with surgical excision first
8. Hypertrophic scars
9. Known hypersensitivity to TAC or 5-FU
10. Chronic systemic corticosteroid or immunosuppressive medication use
11. Has intolerance to anesthesia
12. Has known connective tissue disease
13. Has known infectious disease
18 Years
89 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Nayoung Lee, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20-01172
Identifier Type: -
Identifier Source: org_study_id
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