Fenretinide Mucoadhesive Patch: Evaluation of Oral Cancer Prevention Efficacy in Adults With Premalignant Oral Lesions.

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07149220
Phase
PHASE1
Status
Recruiting
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Conditions

  • Oral Dysplasia
  • Oral Leukoplakia

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Mucoadhesive fenretinide-releasing system (FMS) — DRUG
    All persons with premalignant oral epithelial lesions will receive active intervention. The intervention consists of b.i.d. application of the FMS to the premalignant lesion for a total of six weeks. Please note that the intervention title Drug and intervention titled Other are the same entity.

Study Details

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 your mouth) changes. Specifically, does application of the FMS induce specific changes: 1) reduction in the clinical size, 2) reduction in the histologic grade of precancerous changes (determined by microscopic examination), 3) reduce the nuclear LOH events (changes in copy number of key genes to prevent oral cancer). The first part of this study entails a single FMS application to persons having their wisdom teeth removed. This study is done to confirm how long the FMS needs to remain in place to release the cancer-preventive agent. Participants will: 1) Have the FMS applied over the impacted wisdom tooth for 15 minutes, 2) FMS is removed, saliva is collected, and blood is drawn from a vein in the arm. 3) Tissue overlying the impacted wisdom tooth is removed and analyzed. The second, multi-FMS application entails patients who have precancerous oral surface epithelial changes. These patients will have: 1) a piece of the precancerous tissue removed (biopsy) and examined under a microscope to ensure the diagnosis. Blood is drawn from a vein in the arm., 2) One week after the biopsy, return to discuss the results. If the changes are precancerous, this person will be given FMS to apply to the site twice a day. 3) Patients return every 7 to 10 days (for a total of six weeks) for an oral exam and clinical pictures, return the FMS, and obtain new FMS for the upcoming week., 4) At week 3 (midway), blood is drawn from a vein in the arm., 5) After the six weeks of treatment, clinical pictures are obtained, blood is drawn from a vein in the arm and all of the remaining treated tissue is completely removed. The patient is securely contacted and results are discussed. 6) Approximately 6 weeks after the final surgery, patients return for a complete oral examination and clinical pictures are obtained.

Key Dates

Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Jun 2, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: FMS impact on premalignant oral epithelial lesions
    Evaluation of the impact of the fenretinide-releasing system on premalignant oral epithelial lesions

Primary Outcome Measure

Histopathologic grade (assessed using light microscopy) [ Time Frame: The time frame is 12 months for participant recruitment and completion of the six week clinical trial. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University College of DentistryColumbusOhio43210
Susan R. Mallery, DDS, PhD
[email protected]
6142926577

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By research site
Ohio State University College of Dentistry· Columbus, OH

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