NCT05505539

Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Oral Leukoplakia

Interventions

Type	Name	Description
DRUG	5-fluorouracil	Given intralesionally by injection

Timeline

• Start date: 2022-09-30
• Primary completion: 2023-08-31
• Completion: 2023-12-31
• First posted: 2022-08-17
• Last updated: 2022-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study