Fenretinide mucoadhesive patch to prevent progression of premalignant oral lesions
Safety and Chemopreventive Efficacy of Fenretinide Mucoadhesive System in Subjects With Premalignant Oral Intraepithelial Neoplasia (OIN) Lesions: In Conjunction With Pharmacokinetic Assessment in Healthy Subjects.
PHASE1 · Ohio State University · NCT07149220
This tests whether a sticky fenretinide patch placed on premalignant mouth lesions in adults can shrink the lesion, lower its microscopic grade, and reduce genetic changes linked to oral cancer.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Ohio State University (other) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07149220 on ClinicalTrials.gov |
What this trial studies
The trial uses a mucoadhesive patch that releases fenretinide, a vitamin A derivative, applied directly to oral premalignant lesions. Phase 1 begins with a pharmacokinetic phase where a single patch is applied to the mucosa over an impacted third molar during extraction to determine the needed application time to reach target tissue levels. The second part is a multi-dose, single-center, active formulation-only phase applying the patch to biopsy-confirmed oral intraepithelial neoplasia and monitoring clinical size, histologic grade, and loss-of-heterozygosity events over a six-week treatment period. Saliva, blood, and tissue samples are collected and participants are seen every 7–10 days during treatment for monitoring and follow-up.
Who should consider this trial
Good fit: Adults (18+) with a single biopsy-confirmed oral intraepithelial neoplasia lesion ≥3×3 mm that can be fully covered by the patch, willing to avoid tobacco and attend scheduled visits for six weeks plus follow-up.
Not a fit: Patients with invasive oral cancer, lesions too large or multiple lesions that cannot be covered by one patch, ongoing tobacco use, or inability to comply with follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, the patch could shrink premalignant lesions and reduce their risk of progressing to oral cancer while limiting systemic exposure.
How similar studies have performed: Topical vitamin A–related agents have shown mixed results in oral chemoprevention, and mucoadhesive fenretinide patches represent a relatively novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \- Inclusion Criteria: * 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 Criteria: * \- Exclusion Criteria: * Previous history of OSCC. * Microscopic diagnosis of OSCC or carcinoma in situ at the pretreatment biopsy. * Undergoing cancer treatments except for basal cell carcinoma of the skin. * Inability to stop tobacco product use. * Incapable of providing informed consent. * Pregnancy or unwilling to comply with birth control and monthly pregnancy testing criteria.
Where this trial is running
Columbus, Ohio
- Ohio State University College of Dentistry — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Susan R. Mallery, DDS, PhD — Ohio State University College of Dentistry
- Study coordinator: Susan R. Mallery, DDS, PhD
- Email: mallery.1@osu.edu
- Phone: 614-292-6577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oral Leukoplakia, Oral Dysplasia, oral cancer prevention