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

Phase 4

Completed

• Conditions: Keloid Scar

• Registration Number: NCT04786210
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-25
• Study Start: 2021-01-30
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-08
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Disposition First Submitted: 2023-12-15
• Status Verified: 2024-02
• Results First Submitted: 2024-02-02
• Results First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Results First Posted: 2024-03-26
• Disposition First Posted: 2024-03-26
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Patient and Observer Scar Assessment Scale (POSAS) Score From Baseline to Final Visit	Baseline, Week 16	POSAS has two components, the observer (physician) portion and the patient portion. The observer grades on a scale of 1 to 10, 10 being the worst scar imaginable, six measures: vascularity, pigmentation, thickness, relief, pliability and surface area. The patient answers six questions regarding the characteristics of the scar, with each question being on a scale of 1 to 10. The scores of each category are summed to get the total POSAS score, with 120 being the highest score and representing the worst scar and 12 being the lowest score.
Change in Modified Hamilton Score	Baseline, Week 16	The Hamilton scale consists of 4 items with a score range of 0 to 14, where 14 represents more severe scarring.

Secondary Outcome Measures

Name	Time	Method
Change in Scar Measurement From Baseline to Final Visit	Baseline, Week 16	Scar measurement will be calculated as the total volume (length x width x height) in cm3 of the scar, or (length x width) in cm2 if the scars are flush with the surrounding skin scar surface.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States