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

University of Washington

Status and phase: Enrolling; Phase 3

Conditions: Chalazion

Treatments: Drug: Triamcinolone Acetonide/5-fluorouracil mixture; Drug: Triamcinolone Acetonide; Procedure: Incision and Curettage; Drug: 5-fluorouracil Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02025023

STUDY00003748

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Incision and Curettage

Active Comparator group

Description:

A vertical incision over the area of chalazion will be done. Inflammatory material will be removed and the chalazion capsule will be excised.

Treatment:

Procedure: Incision and Curettage

Injection of Triamcinolone Acetonide

Active Comparator group

Description:

0.1 ml of triamcinolone is injected directly in the chalazion.

Treatment:

Procedure: Incision and Curettage

Drug: Triamcinolone Acetonide

Injection of 5-fluorouracil

Active Comparator group

Description:

0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.

Treatment:

Drug: 5-fluorouracil Injection

Procedure: Incision and Curettage

Injection of triamcinolone/5FU mixture

Active Comparator group

Description:

0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.

Treatment:

Procedure: Incision and Curettage

Drug: Triamcinolone Acetonide/5-fluorouracil mixture