Topical and oral metformin to prevent or shrink oral leukoplakia
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial
This study will test whether using metformin both as a mouth application and as oral tablets can shrink or prevent early oral leukoplakia in adults with mild-to-moderate dysplasia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07387900 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults over 21 with clinically and histologically confirmed oral leukoplakia with mild-to-moderate dysplasia who are not taking metformin and can provide informed consent.
Not a fit: Patients with severe dysplasia, significant cardiac/respiratory/renal/hepatic disease, current metformin therapy, pregnancy or lactation, or other concurrent oral lesions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the combined topical and oral metformin approach could shrink lesions or reduce the chance they become cancerous, offering a less invasive option than surgery.
How similar studies have performed: Other chemoprevention trials using agents like vitamin A, green tea extract, and some small metformin studies show limited promise, but combined topical plus systemic metformin is a relatively novel approach without definitive proof yet.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Refaat Ghanem, MSc
- Email: Mohamed-Refaat@dentistry.cu.edu.eg
- Phone: +02 01221493237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.