Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Kyle Jones, DDS, PhD
Headshot of Kyle Jones
Kyle Jones

Description

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).

Official Title

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

Details

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

Oral Leukoplakia Leukoplakia Leukoplakia, Oral Fluorouracil 5-fluorouracil

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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
  • Ability to understand and willingness to sign a written informed consent document
  • Willingness to provide blood and tissue from diagnostic biopsies
  • Any smoking history is permitted

You CAN'T join if...

  • 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
  • History of allergic reaction or severe hypersensitivity to 5-FU and/or lidocaine
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Location

  • University of California, San Francisco
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Kyle Jones, DDS, PhD
    HS ASST CLINICAL PROFESSOR, Orofacial Sciences, School of Dentistry. Authored (or co-authored) 8 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05505539
Phase
Phase 1 Oral Leukoplakia Research Study
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated