Study of Combined Topical and Oral Metformin to Prevent Progression of Oral Leukoplakia in Adults

What this Trial Is About

Researchers are studying oral leukoplakia, a condition where white patches form in the mouth that may turn into cancer. There is no agreed best treatment, though surgery is often used. This research aims to evaluate how well a combination of topical and systemic metformin works to prevent the growth or worsening of these lesions, especially before they become cancerous. This is a phase 2 randomized clinical trial sponsored by Cairo University. The trial compares two groups one receiving a 10% metformin oral gel plus 500mg metformin tablets, and the other receiving placebo gel and tablets. Participants will apply the gel and take the tablets over a period monitored by the study. Treatments are given in a quadruple-masked setting to prevent bias. The study focuses on assessing changes in the size of the oral leukoplakia lesions over 6 months. Participants will be adults over 21 years with mild to moderate dysplasia confirmed by clinical and histological diagnosis. They will be regularly assessed for lesion size changes and monitored for safety. The main outcome is the change in lesion size at 6 months. The total participation time covers treatment and follow-up visits to evaluate the preventive effect and any side effects of the combined metformin treatment.

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