Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin Hydrochloride, Placebo.
- Who it may be relevant to
- Registry conditions: Oral Leukoplakia. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial
Overview
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.
Interventions
- Drug Metformin Hydrochloride
10% oral gel and 500mg tablet - Drug Placebo
Placebo Gel and 500mg Placebo tablet
Primary outcome measures
- Change in lesion size [Time frame: over 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07387900 · OMED 3.7.2