What side effects are associated with this type of intervention?

Common treatments for chalazion, such as local injections of 5-Fluorouracil (5-FU), triamcinolone, and incision and curettage, have specific side effects. 5-FU, which inhibits DNA synthesis to reduce cell proliferation, can cause local irritation, pain, swelling, and potential infection at the injection site. Triamcinolone injections may lead to skin thinning, depigmentation, and increased intraocular pressure. Incision and curettage carry risks of bleeding, infection, and scarring.

What prior FDA approvals exist?

The treatment of chalazion has traditionally included methods such as local injection of triamcinolone (a corticosteroid) and surgical procedures like incision and curettage. Recently, studies have shown that local injection of 5-Fluorouracil, which inhibits DNA synthesis to reduce cell proliferation, is as effective as these traditional methods. However, specific FDA approvals for 5-Fluorouracil in the treatment of chalazion are not detailed in the provided context.

What other types of research exist?

A promising alternative to 5-Fluorouracil for treating chalazion in 2024 could be doxycycline, especially for severe cases associated with other conditions. Consultation with a healthcare provider is recommended to determine the best treatment option.

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Anti-metabolites

5-Fluorouracil Injection for Chalazion (CTS Trial)

Phase 3

Recruiting

Led By Matthew M Zhang, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Single or multiple chalazia in a single eyelid

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Approved for 10 Other Conditions

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial compares different treatments for eyelid lumps called chalazia. The treatments include medicine injections or minor surgery. The goal is to see which method best reduces or removes these lumps. Injections have been used effectively in treating chalazia, showing high success rates in previous studies.

Who is the study for?

This trial is for individuals with one or more chalazia (styes) on a single eyelid. Participants must have had the chalazion for at least one month and should not have received any previous injections or surgical treatments for it.

What is being tested?

The study is testing the effectiveness of a local injection of 5-fluorouracil compared to an injection of triamcinolone (a steroid), a mixture of both, or surgery (incision and curettage) in treating chalazia.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, inflammation, possible skin discoloration, and eye irritation. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have one or more chalazia on one eyelid.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My chalazion has been present for less than a month and hasn't been treated by injection or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Injection of triamcinolone/5FU mixtureActive Control2 Interventions

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

Group II: Injection of Triamcinolone AcetonideActive Control2 Interventions

0.1 ml of triamcinolone is injected directly in the chalazion.

Group III: Incision and CurettageActive Control1 Intervention

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

Group IV: Injection of 5-fluorouracilActive Control2 Interventions

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chalazion include local injection of 5-Fluorouracil (5-FU), triamcinolone (a steroid), and incision and curettage. 5-FU works by inhibiting DNA synthesis, thereby reducing cell proliferation and effectively shrinking the lesion. Triamcinolone reduces inflammation and immune response, which helps in decreasing the size of the chalazion. Incision and curettage involve surgically opening the chalazion and removing its contents. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options based on the underlying cause and severity of their condition.

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