Suspended

OL_5FUIntralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia: a Pilot Study

What is being tested

5-fluorouracil

Drug

Who is being recruted

Head and Neck Neoplasms+8

+ Leukoplakia

+ Leukoplakia, Oral

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: September 2022

See protocol details

Summary

Principal SponsorUniversity of California, San Francisco

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2022

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVE: I. Evaluate the feasibility of intralesional 5-fluorouracil (5-FU) injection for the treatment of oral leukoplakia SECONDARY OBJECTIVE: I. Evaluate the safety profile and side effects of the study drug. OUTLINE: Participants diagnosed with OL will receive multiple intralesional injections of 5-FU solution over a maximum period of 6 weeks, followed by a follow-up visit after 3 months.

Official TitleIntralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia: a Pilot Study

NCT05505539

Principal SponsorUniversity of California, San Francisco

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Head and Neck NeoplasmsLeukoplakiaLeukoplakia, OralStomatognathic DiseasesMouth DiseasesMouth NeoplasmsNeoplasmsNeoplasms by SitePrecancerous ConditionsPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Criteria

7 inclusion criteria required to participate

Adults, 18 years of age or older

Any gender, race, or ethnicity

Clinical diagnosis of oral leukoplakia and biopsy proven dysplasia (any grade)

Oral leukoplakia at least 1 cm in largest diameter

Show More Criteria

6 exclusion criteria prevent from participating

Pregnant or lactating women

Men and women unwilling to use contraception while on study

History of malignancy that required cytotoxic chemotherapy within the previous 3 months

Use of 5-FU (systemic or topical) within 3 months prior to study enrollment

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive up to 3 intralesional 5-fluorouracil injections (0.25 mL of a 50mg/mL solution) once every 2 weeks into an oral leukoplakia lesion.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of California, San Francisco

San Francisco, United StatesOpen University of California, San Francisco in Google Maps

SuspendedOne Study Center