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
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
Treatments tested in this trial
- Metformin Hydrochloride
- Placebo
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov