Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid

  • STATUS
    Recruiting
  • End date
    Mar 26, 2023
  • participants needed
    20
  • sponsor
    NYU Langone Health
Updated on 26 March 2022

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 of triamcinolone acetonide. Patients will undergo treatments in a series of 4 treatments at approximately 4 week ± 1 week intervals. Investigators will monitor for safety and continued benefit after the end of the interventional treatment.

Details
Condition Keloid Scar
Treatment Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil, Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
Clinical Study IdentifierNCT04786210
SponsorNYU Langone Health
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

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
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