RecruitingPhase 2NCT07387900

Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia

Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial


Sponsor

Cairo University

Enrollment

34 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Chemoprevention is a new direction in the management of OL using various topical and systemic agents such as; vitamin A, lycopene, celecoxib, green tea extract, and metformin. While metformin cannot realistically be used as cancer mono-therapy, it can be used as an adjunct and can have a more promising effect on lesions that have yet to undergo malignant transformation. Thus, the aim of this study is to investigate the efficacy of combined chemo-preventive effect of topical and systemic Metformin on oral leukoplakia.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether metformin — a widely used diabetes medication — applied both topically (directly to the mouth lesion as a cream) and taken orally (as a pill) can prevent oral leukoplakia (white patches inside the mouth that can become cancerous) from progressing to cancer. **You may be eligible if...** - You are an adult over 21 years old - You have been diagnosed with oral leukoplakia confirmed by biopsy - Your lesion shows mild to moderate cell changes (dysplasia) - You are willing to sign an informed consent form **You may NOT be eligible if...** - Your lesion shows severe dysplasia (more advanced cell changes) - You have heart, lung, kidney, or liver disease - You already take metformin (e.g., for diabetes or PCOS) - You take medications that interfere with metformin absorption (such as certain acid reflux drugs) - You are allergic to metformin - You are currently taking retinoids, green tea supplements, or other natural product therapies for your lesion - You have other active lesions in your mouth - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin Hydrochloride

10% oral gel and 500mg tablet

DRUGPlacebo

Placebo Gel and 500mg Placebo tablet


Locations(1)

Cairo University

Cairo, Egypt

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NCT07387900


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