Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
Recruiting
Phase 2
Interventional Study
Oral Leukoplakia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 21 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 34 (estimated)
- Sponsor
- Cairo University · Other
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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 realistica…
Trial Locations
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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 Cr…
Contacts