Actively Recruiting
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial
Led by Cairo University · Updated on 2026-02-06
34
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Patients with lesions showing severe degree of dysplasia.
- Patients who have cardiovascular, lung, renal, or liver diseases.
- Patients currently on metformin therapy (e.g., for diabetes mellitus, PCOS).
- Patients on H2 blockers or proton pump inhibitors like ranitidine that affect metformin.
- Patients allergic or sensitive to metformin or with contraindications to its use.
- Patients using retinoids, green tea supplements, or other natural product therapies.
- Patients with other accompanying oral lesions.
- Pregnant or lactating females.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive combined topical and systemic metformin or placebo to evaluate the chemo-preventive effect on oral leukoplakia.
Monthly visits during treatment
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt
Actively Recruiting
Research Team
M
Mohamed Refaat Ghanem, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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