NCT02025023

Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection of triamcinolone (steroid) and incision and curettage for treatment of chalazia.

Detailed description

This is a prospective randomized interventional study comparing four current standard-of-care treatments for chalazia: incision and curettage, local injection of triamcinolone, local injection of 5-FU, and local injection of combination triamcinolone/5-FU.

Conditions

• Chalazion

Interventions

Type	Name	Description
DRUG	5-fluorouracil Injection	If the chalazion is present at follow-up visit, another injection of 5-FU will be given.
DRUG	Triamcinolone Acetonide	If chalazion present at follow-up, another Triamcinolone injection will be done.
PROCEDURE	Incision and Curettage	If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture.
DRUG	Triamcinolone Acetonide/5-fluorouracil mixture	If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.

Timeline

• Start date: 2013-12-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2013-12-31
• Last updated: 2020-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study