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Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia — OL_5FU  

Oral Leukoplakia Clinical Trial

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

Clinical Trial Summary

This is a single center, open-label, interventional pilot study to assess the feasibility, safety, and preliminary efficacy of intralesional 5-FU injections for the treatment of oral leukoplakia (OL).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05505539
Study type Interventional
Source University of California, San Francisco
Contact
Status Withdrawn
Phase Phase 1
Start date September 30, 2022
Completion date December 31, 2023
View Details
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