Phase 2 Study of Pioglitazone and Metformin Treatment for High Risk Oral Leukoplakia Assessing Clinical and Tissue Changes After 12 Weeks of Therapy

What this Trial Is About

Researchers are evaluating a combination treatment of pioglitazone and metformin for people with high risk oral leukoplakia, a precancerous condition in the mouth. This Phase IIa study aims to observe clinical and tissue changes in leukoplakia after a 12-week treatment period. The primary goal is to reduce the severity grade of leukoplakia and achieve at least a 50% reduction in lesion size, along with measuring changes in cell growth markers in the lesions. Participants will receive oral doses of pioglitazone 15mg combined with metformin 500mg twice daily for 12 weeks. The study involves 36 patients with measurable oral leukoplakia lesions in high risk areas of the mouth or oropharynx. The lesions must be accessible for biopsy before and after treatment to assess histologic changes and cell proliferation. During the study, participants will be monitored for changes in their oral lesions through clinical examinations and tissue biopsies. The research team will measure clinical response, histologic changes, and Ki-67 cell proliferation markers after 12 weeks or if treatment ends early. Participants must be able to swallow tablets and comply with the treatment schedule. The study expects to last until mid-2027, with assessments focused on lesion changes and safety monitoring throughout.

Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia