Clinical Trial: Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Condition: Oral Leukoplakia
Study Type: INTERVENTIONAL
Official Title: Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Brief Summary:
This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks.The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin.Outcomes are defined as are a reduction of the leukoplakia grade in > 50% of treated participants and a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions.In addition,…
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