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

Chalazion Clinical Trial

— CTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02025023
• Other study ID #: STUDY00003748
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2013
• Est. completion date: July 2026

Study information

• Verified date: February 2020
• Source: University of Washington
• Contact: Simona Vuletic
• Phone: 206-520-9728
• Email: simona[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Single or multiple chalazia in a single eyelid

Exclusion Criteria:

• Chalazia present for less than one month and no previous injection or incision and curettage

Related Conditions & MeSH terms

• Chalazion

Intervention

Drug:
• 5-fluorouracil Injection
If the chalazion is present at follow-up visit, another injection of 5-FU will be given.
• 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.

Locations

Country	Name	City	State
United States	University of Washington Eye Institute at Harborview	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of chalazion		4 weeks