Phase 2: testing Metformin Hydrochloride for Oral Leukoplakia
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.
Official registry: https://clinicaltrials.gov/study/NCT07387900 · Cairo University · enrollment listed as 34
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Metformin Hydrochloride, or Placebo. The registry lists allocation as randomized. 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.
They plan to enroll about 34 people at Cairo. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial
Interventions: Metformin Hydrochloride, Placebo
Primary outcome (registry wording): Change in lesion size
Who it is for (from inclusion criteria)
- Ages 21 Years to any
- 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
Who the registry excludes
- 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
Public study contact (from the registry)
Mohamed Refaat Ghanem, MSc
Mohamed-Refaat@dentistry.cu.edu.eg
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Cairo University — Cairo, Egypt (recruiting)
FAQ about this NCT record
Is NCT07387900 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07387900?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07387900?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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