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

Conditions

• Oral Submucous Fibrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• Metformin Hydrochloride — DRUG
  Group B will receive Metformin 500 mg thrice daily. Group C will receive topical cream metformin thrice daily.
• betamethasone dipropionate — DRUG
  Group 1will recieve topical cream betamethasone thrice daily
• Pentoxifylline — DRUG
  Group 1 will receive Pentoxifylline tablet 400 mg twice daily

Study Details

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

Key Dates

Start date

Aug 12, 2024

Status verified

Apr 2025

Primary completion

Dec 30, 2024

Completion

Jan 6, 2025

Study Design

Enrollment

30 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard
  Group 1: Standard treatment with topical cream betamethasone and Pentoxifylline tablet.
• Experimental: MetforminO
  Metformin 500 mg thrice daily.
• Experimental: MetforminT
  Topical cream metformin thrice daily

Primary Outcome Measure

Cell Viability [ Time Frame: 8 months ]