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

Plain-language summary

This study examines the effectiveness of a fenretinide-releasing mucoadhesive patch (FMS) in preventing oral cancer in adults with premalignant (potentially cancer-forming) mouth lesions. Adults aged 18 and older with a single microscopically confirmed measurable lesion who do not use tobacco products during the study may take part. The study is being conducted in Phase 1 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Active, not recruiting

Sponsor

Ohio State University Comprehensive Cancer Center

Intervention

Mucoadhesive fenretinide-releasing system (FMS)

Start date

10/14/2025

Estimated completion

7/1/2026

Countries

United States

Related genes

Locations

• Columbus, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.