Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia

Conditions

• Oral Leukoplakia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• pioglitazone-metformin — DRUG
  Treatment with pioglitazone-metformin (15mg/500mg) twice a day for 12 weeks

Study Details

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, participants who show clinical and histologic improvement should correlate with a significant reduction of Ki-67 proliferative indices in lesions of these participants as compared to baseline.

Key Dates

Start date

Jan 1, 2025

Status verified

Dec 2025

Primary completion

Jul 28, 2026

Completion

Jul 28, 2026

Study Design

Enrollment

36 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: oral leukoplakia patients
  36 total high risk oral leukoplakia patients.

Primary Outcome Measure

Clinical change in leukoplakia [ Time Frame: after 12 weeks of intervention or at early termination. ]

Central Contacts

• Beverly Wuertz
  612-625-3090
  [email protected]

Locations (2)

Find similar trials in Minneapolis, MN

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  PHASE1 · Recruiting · Ohio State University · Columbus, Ohio