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

NCT07387900 | Recruiting Phase 2

• 1 other identifier: OMED 3.7.2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Leukoplakia

Keywords

Oral Leukoplakia; Metformin

Outcome Measures

Primary Outcomes (1)

• Change in lesion size

  the lesion will be measured in size by periodontal probe bi-dimensionally in mms

  over 6 months

Study Arms (2)

Topical and systemic metformin

EXPERIMENTAL

Drug: Metformin Hydrochloride

Topical and systemic Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Metformin Hydrochloride DRUG

10% oral gel and 500mg tablet

Topical and systemic metformin

Placebo DRUG

Placebo Gel and 500mg Placebo tablet

Topical and systemic Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Leukoplakia, Oral

Interventions

Metformin

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Mohamed Refaat Ghanem, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

EG (1)