Phase 4
N=19
Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
Keloid Scar
Bottom Line
View on ClinicalTrials.gov: NCT04786210 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit — -20; -20.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil (Combination_product); Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit |
-20; -20.6 | — |
| PRIMARY Change in Modified Hamilton Score |
-0.88; -1.36 | — |
| SECONDARY Change in Scar Measurement From Baseline to Final Visit |
-368.7; -310.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04786210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.