Safety and Chemopreventive Efficacy of Fenretinide Mucoadhesive System in Subjects With Premalignant Oral Intraepithelial Neoplasia Lesions: Pharmacokinetic Assessment in Healthy Subjects

What this Trial Is About

Researchers are evaluating the effect of a mucoadhesive system releasing fenretinide, a vitamin A derivative, on precancerous changes in the lining tissue inside the mouth. This trial aims to see if applying this system reduces the size and severity of premalignant oral lesions and decreases genetic changes linked to oral cancer. The study includes adults with confirmed premalignant oral intraepithelial neoplasia (OIN) lesions and involves a phase 1 clinical trial design. The study has two parts: first, a single application of the fenretinide patch on healthy subjects undergoing wisdom tooth removal to determine the optimal application time needed to reach target drug levels. Second, patients with confirmed premalignant oral lesions will apply the fenretinide mucoadhesive system twice daily for six weeks. Participants return every 7 to 10 days for exams, photos, patch replacement, and blood sampling. After treatment, remaining lesion tissue is surgically removed and healing is monitored. Participants undergo initial biopsies to confirm diagnosis and provide baseline data. During treatment, oral exams, clinical photos, saliva, and blood samples are collected regularly to monitor response and medication adherence. After six weeks of treatment and excision, follow-up visits include assessments of healing and lesion status. The primary outcomes measured are lesion size, microscopic grade of precancerous changes, and genetic markers. The total participation time varies between about 20 minutes for healthy subjects and up to 9 weeks for patients with lesions.

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