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New treatment option for Oral Leukoplakia
Official title Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
ClinicalTrials.gov ID: NCT07387900
What this study is testing
What is Metformin Hydrochloride?
Metformin Hydrochloride is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for oral leukoplakia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.