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

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT02025023

Collaborator

(none)

120

Enrollment

Location

Arms

151

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chalazion	Drug: 5-fluorouracil Injection Drug: Triamcinolone Acetonide Procedure: Incision and Curettage Drug: Triamcinolone Acetonide/5-fluorouracil mixture	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Incision and Curettage A vertical incision over the area of chalazion will be done. Inflammatory material will be removed and the chalazion capsule will be excised.	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.
Active Comparator: Injection of Triamcinolone Acetonide 0.1 ml of triamcinolone is injected directly in the chalazion.	Drug: Triamcinolone Acetonide If chalazion present at follow-up, another Triamcinolone injection will be done. Other Names: triamcinolone 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.
Active Comparator: Injection of 5-fluorouracil 0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.	Drug: 5-fluorouracil Injection If the chalazion is present at follow-up visit, another injection of 5-FU will be given. Other Names: 5-FU 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.
Active Comparator: Injection of triamcinolone/5FU mixture 0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.	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.