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NCT Number: NCT07387900

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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University

Cairo, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin Hydrochloride

Drug

10% oral gel and 500mg tablet

Placebo

Drug

Placebo Gel and 500mg Placebo tablet

Primary outcomes

  1. Change in lesion size

    Time frame: over 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Refaat Ghanem, MSc

CONTACT

[email protected]

+02 01221493237

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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