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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07387900

Enrollment

Registered

2026-02-04

Start date

2026-02-01

Completion date

2027-10-01

Last updated

2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Leukoplakia

Keywords

Oral Leukoplakia, Metformin

Brief 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.

Interventions

DRUGMetformin Hydrochloride

10% oral gel and 500mg tablet

DRUGPlacebo

Placebo Gel and 500mg Placebo tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change in lesion size	over 6 months	the lesion will be measured in size by periodontal probe bi-dimensionally in mms

Countries

Egypt

Contacts

CONTACTMohamed Refaat Ghanem, MSc

Mohamed-Refaat@dentistry.cu.edu.eg+02 01221493237

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026