CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil +1 morecombination
Likely dose
Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04786210
NCT04786210Phase 4Completed
CompareCT.gov

A Prospective Triple-Blinded Single-Center Study of Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid Treatment for Keloids

NYU Langone Health·interventional·Posted Mar 8, 2021·Updated Mar 26, 2024

In Brief

A Phase 4 clinical trial evaluating Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide for Keloid Scar. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeloid Scar
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMar 8, 2021
Enrollment StartJan 30, 2021
Primary CompletionDec 16, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.3 years ago

Interventions

Fractional erbium:YAG-assisted drug delivery of 5-fluorouracilcombination

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 acetonidecombination

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)