Could a common diabetes drug stop precancerous mouth lesions?

NCT ID NCT07387900

Disease control Sponsor: Cairo University Source: ClinicalTrials.gov ↗

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

Summary

This study tests whether metformin, a diabetes drug, can shrink or prevent precancerous mouth patches called oral leukoplakia. Researchers will give 34 adults a metformin gel applied to the lesion plus a metformin pill, or placebos. The goal is to see if the combination reduces lesion size and lowers cancer risk.

What this could mean

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

Active substance: Metformin (10% oral gel and 500mg tablet)
What this could lead to: If it works, this could offer a non-surgical way to reduce oral leukoplakia lesions and lower the risk of them turning into cancer.
What could go wrong: This is a small early-phase trial with only 34 people, so results may not apply to everyone. Metformin is not a proven cancer treatment, and the benefit may be modest or absent.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 34 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

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

21 years and older

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: * Adult patients over 21 years. * Patients clinically diagnosed and histologically confirmed as having oral Leukoplakia. * Lesions with mild to moderate degree of dysplasia. * Patients who agree to sign a written consent after understanding the nature of the study. Exclusion Criteria: * Patients with lesions showing sever degree of dysplasia. * Patients who have cardiovascular, lung, Renal, Liver diseases * Patients on metformin therapy (eg: Diabetes Mellitus, PCOS, …etc.) * Patients on H2 blocker \& proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance) * Those with allergy or sensitivity to Metformin therapy or having any contraindication for their use. * Patients on Retinoid, green tea supplements or another natural products therapy * Patients with other accompanying oral lesions * Pregnant or Lactating females

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Conditions

The condition(s) this trial relates to.

oral mucosa leukoplakia

As listed by the trial registrant

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

Oral leukoplakia

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a common diabetes drug stop precancerous mouth lesions?

What the study statuses mean