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

NCT07387900 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-02-06

No results posted yet for this study

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

DRUG

Metformin Hydrochloride

10% oral gel and 500mg tablet

DRUG

Placebo

Placebo Gel and 500mg Placebo tablet

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-09-30
Completion
2027-10-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07387900 on ClinicalTrials.gov