Topical and oral metformin to prevent or shrink oral leukoplakia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial compares combined topical and systemic metformin against placebo in adults with histologically confirmed oral leukoplakia showing mild-to-moderate dysplasia. Participants will receive a topical metformin formulation applied to the lesion plus oral metformin tablets, or matching placebos, and will be followed over time for clinical and histologic changes. Key outcomes include change in lesion size, change in degree of dysplasia, and safety/tolerability of the combined regimen. The protocol excludes patients with severe dysplasia, major organ disease, current metformin use, recent interfering supplements or medications, and pregnant or lactating women.

Why it matters

Who can join: the full rules

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

Where it's running

• Cairo University
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Mohamed Refaat Ghanem, MSc
• Email: Mohamed-Refaat@dentistry.cu.edu.eg
• Phone: +02 01221493237

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.