RecruitingPhase 2NCT07387900

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

Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial

Sponsor

Cairo University

Enrollment

34 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Oral Leukoplakia

Summary

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria4

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 Criteria8

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