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

NCT ID: NCT02025023

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chalazion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Incision and Curettage

Intervention Type PROCEDURE

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.

Injection of Triamcinolone Acetonide

0.1 ml of triamcinolone is injected directly in the chalazion.

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type DRUG

If chalazion present at follow-up, another Triamcinolone injection will be done.

Incision and Curettage

Intervention Type PROCEDURE

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.

Injection of 5-fluorouracil

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

Group Type ACTIVE_COMPARATOR

5-fluorouracil Injection

Intervention Type DRUG

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

Incision and Curettage

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Incision and Curettage

Intervention Type PROCEDURE

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.

Triamcinolone Acetonide/5-fluorouracil mixture

Intervention Type DRUG

If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

5-fluorouracil Injection

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

Intervention Type DRUG

Triamcinolone Acetonide

If chalazion present at follow-up, another Triamcinolone injection will be done.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Triamcinolone Acetonide/5-fluorouracil mixture

If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

5-FU triamcinolone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matthew Zhang

Assistant Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthew M Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington Eye Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington Eye Institute at Harborview

Seattle, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Simona Vuletic

Role: CONTACT

206-520-9728

Ian Luttrell

Role: CONTACT

206-520-8305

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Simona Vuletic

Role: primary

206-520-9728

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00003748

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Topical Imiquimod Treatment of Oral Dysplasia
NCT07210775 RECRUITING PHASE1/PHASE2
Treatment of Epidermoid Cysts
NCT05597995 UNKNOWN PHASE2
Imiquimod for Preventing Keloid Recurrence
NCT03760250 TERMINATED PHASE2