drugset / Trial / NCT06332612

Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial

NCT06332612

Phase 1/2 Completed 30 enrolled Ziauddin University
RandomizedParallel-groupSingle-blindTreatment

Summary

OSF is a widespread health issue in Asian countries, notably Pakistan, linked to the consumption of pan, chalia, and gutka, affecting a rising number of young individuals as an epidemic. This condition significantly impairs oral function, resulting in ulcers and chronic lesions, often progressing to oral cancer. Current treatments focus on symptom relief and halting disease progression. This study explores the repurposing of metformin, an FDA-approved drug with antifibrotic properties, for OSF treatment. Our objective is to unveil its therapeutic potential and comprehend its impact on the dysregulated signaling pathways associated with OSF. This research offers promising insights for an enhanced management approach, providing hope for those grappling with this debilitating condition

Timeline

Start
2024-08-12
Primary completion
2024-12-30
Completion
2025-01-06

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg Oral
Comparator Pentoxifylline Small molecule 400 mg Oral
Comparator betamethasone dipropionate Small molecule Topical