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

NCT07387900 — Phase 2, Recruiting, 34 participants, Cairo University

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

Registry	NCT07387900
Status	Recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	34 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Oral Leukoplakia
Interventions	Metformin Hydrochloride, Placebo (Drug)
Dates	start 2026-02-01 (estimated), primary completion 2027-09-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-02-04, last updated 2026-02-06
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Topical and systemic metformin	Experimental	Drug: Metformin Hydrochloride
Topical and systemic Placebo	Placebo comparator	Drug: Placebo

Metformin Hydrochloride (Drug): 10% oral gel and 500mg tablet
Placebo (Drug): Placebo Gel and 500mg Placebo tablet

+Outcome measures

Primary outcomes

Change in lesion size [over 6 months]: the lesion will be measured in size by periodontal probe bi-dimensionally in mms

+Eligibility

Sex: All, ages: 21 Years to any

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

+Locations (1)

Facility	City	Country	Status
Cairo University	Cairo	Egypt	Recruiting