Spots Global Cancer Trial Database for Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia
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Trial Identification
Brief Title: Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia
Official Title: Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia: a Pilot Study
Study ID: NCT05505539
Conditions
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, San Francisco, San Francisco, California, United States
Contact Details
Name: Kyle Jones, DDS, PhD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
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