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First received: January 19, 2023

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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