Actively Recruiting
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
Led by Cairo University · Updated on 2026-02-06
34
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 on metformin therapy (e.g., for Diabetes Mellitus, PCOS).
- Patients on H2 blocker or proton pump inhibitor therapy such as Ranitidine.
- Patients with allergy or sensitivity to Metformin or contraindications for 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt
Actively Recruiting
Research Team
M
Mohamed Refaat Ghanem, MSc
CONTACT
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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