NCT07387900

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Leukoplakia

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride	10% oral gel and 500mg tablet
DRUG	Placebo	Placebo Gel and 500mg Placebo tablet

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-09-01
• Completion: 2027-10-01
• First posted: 2026-02-04
• Last updated: 2026-02-06

Locations

1 site across 1 country: Egypt