Status:
RECRUITING
Fenretinide Mucoadhesive Patch: Evaluation of Oral Cancer Prevention Efficacy in Adults With Premalignant Oral Lesions.
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Oral Leukoplakia
Oral Dysplasia
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to determine the effect of a mucoadhesive system that releases the vitamin A derivative, fenretinide (FMS), on precancerous surface epithelial (lining tissue inside ...
Detailed Description
1 Protocol Summary Overall Design The initial single patch application pharmacokinetic analysis on persons undergoing elective oral surgical procedures (third molar extraction) is being conducted to d...
Eligibility Criteria
Inclusion
- \-
- Adults, 18 years or older, with microscopically confirmed OIN. Only one clinically measurable OIN lesion (\> 3x3 mm) and capable of full coverage by the FMS with a small zone of extension (2.1 x 2.1 cm smaller FMS, 2.8 x 2.8 larger FMS) will be evaluated in this study. If multiple suspicious lesions are noted, the most clinically advanced lesion will be selected for treatment. The patient will be provided the option to have the other lesions biopsied (self-pay and/or insurance) at another appointment or to schedule with another provider for management.
- No use of tobacco products 6 weeks prior to and during the 6-week study. (confirmed via random cotinine saliva tests for former tobacco users).
- Available for follow-up evaluations (every 7-10 days during trial), amenable to full 6-week study participation, and 6-week post-study recall.
- All men and reproductive aged women of child bearing potential must agree to use contraception during treatment and 1 month after end of treatment. All reproductive aged, heterosexually active women must undergo monthly pregnancy testing.
- Capable of providing informed consent.
Exclusion
- \-
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07149220
Start Date
September 1 2025
End Date
August 30 2026
Last Update
August 29 2025
Active Locations (1)
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1
Ohio State University College of Dentistry
Columbus, Ohio, United States, 43210