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Vitamin a derivative patch could reverse oral precancer

NCT ID NCT07149220

Disease control Sponsor: Ohio State University Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests a sticky patch that releases fenretinide, a vitamin A derivative, directly onto precancerous spots inside the mouth. The goal is to see if the patch can shrink these lesions, reduce their severity under the microscope, and lower genetic changes linked to oral cancer. The study involves healthy volunteers and people with confirmed oral precancer, who apply the patch twice daily for six weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fenretinide mucoadhesive system
What this could lead to
If effective, this patch could offer a non-surgical way to reverse precancerous mouth lesions and lower the risk of oral cancer.
What could go wrong
This is a small early-phase trial, so results may not confirm effectiveness. The patch may cause irritation or fail to shrink lesions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

intraepithelial neoplasia oral mucosa leukoplakia lip and oral cavity carcinoma prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oral dysplasia Oral leukoplakia

Contacts and locations

Locations

  • Ohio State University College of Dentistry

    Columbus, Ohio, 43210, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.