drugset / Trial / NCT04786210

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

NCT04786210

Phase 4 Completed 20 enrolled NYU Langone Health
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2021-01-30
Primary completion
2022-12-16
Completion
2022-12-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Triamcinolone Acetonide Other / unclassified 10 mg/ml Other
Subject fluorouracil Small molecule 50 mg/ml Other

Indications