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

RecruitingPhase 2Ages 21 Years - anyAllCairo University
NCT07387900 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Metformin Hydrochloride
  • Placebo
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Where

1 site
Cairo University
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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