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

ConditionOral Leukoplakia

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age21+

SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

34 Participants

are divided into 2 treatment groups

Group A: Topical and systemic metforminExperimental treatment 1 intervention

Group B: Topical and systemic PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in lesion size

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

Time frame

over 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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