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OncoMatch/Clinical Trials/NCT07387900

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

Is NCT07387900 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Metformin Hydrochloride for oral leukoplakia.

Phase 2RecruitingCairo UniversityNCT07387900Data as of May 2026

Treatment: Metformin HydrochlorideThere 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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Extracted eligibility criteria

Prior therapy

Cannot have received: metformin (metformin)

Patients on metformin therapy (eg: Diabetes Mellitus, PCOS, …etc.)

Cannot have received: H2 blocker (ranitidine)

Patients on H2 blocker & proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)

Cannot have received: proton pump inhibitor

Patients on H2 blocker & proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)

Cannot have received: retinoid

Patients on Retinoid, green tea supplements or another natural products therapy

Cannot have received: green tea supplements

Patients on Retinoid, green tea supplements or another natural products therapy

Cannot have received: natural products therapy

Patients on Retinoid, green tea supplements or another natural products therapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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