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

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Leukoplakia
• Intervention / Treatment: Drug: Metformin Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mohamed Refaat Ghanem, MSc; Phone Number: +02 01221493237; Email: Mohamed-Refaat@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical and systemic metformin	Drug: Metformin Hydrochloride; 10% oral gel and 500mg tablet
Placebo Comparator: Topical and systemic Placebo	Drug: Placebo; Placebo Gel and 500mg Placebo tablet

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Metformin; Oral Leukoplakia
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Head and Neck Neoplasms; Precancerous Conditions; Mouth Neoplasms; Pathological Conditions, Signs and Symptoms; Leukoplakia; Leukoplakia, Oral; Organic Chemicals; Biguanides; Guanidines; Amidines; Metformin
• Other Study ID Numbers: OMED 3.7.2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No