Repurposing Metformin for the Treatment of Oral Submucous Fibrosis: Unraveling Novel Signaling Pathways In Vitro and Advancing to Clinical Trial"

8420224AROM

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

2024-03-01

2024-09-01

2024-12-01

Not yet recruiting

Early phase I

30

Inclusion Criteria: 1. Patients with OSF- palpable bands on oral examination 2. Patients with limited mouth opening due to OSF 3. Patients who have not received any treatment for OSF in the previous three months 4. Patients with habits of pan, Chalia, Ghutka 5. Age group between 18 and 45 years Exclusion Criteria: 1. Patients presenting with both OSCC and OSF 2. Patients with limited mouth opening due to impaction of the third molar (impaction of third molar results in limited mouth opening hence such patients are excluded since limited mouth opening due to third molar impaction can be mistaken for OSF). 3. Patients with limited mouth opening due to temporomandibular joint disorder (temporomandibular joint disorders can limit the ability of patient to open their mouth and hence can be mistaken for OSF) 4. Any history of Metformin intolerance or contraindications. 5. Presence of other severe medical conditions along with drug therapy. 6. Pregnancy or lactation. 7. Participation in other clinical trials concurrently. 8. Inability to provide informed consent.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. In Vitro (Cell Line) Study Design: Experimental in vitro study using OSF cell lines.\n\nGroups:\n\n* Metformin-treated\n* Control (untreated)\n* Vehicle control Clinical Trial Study Design: A pilot Randomized Controlled Trial (RCT) translating the in vitro findings into a clinical setting. It would be a single-blind, placebo-controlled designAll groups will undergo a 24-week intervention phase. Group 1 will receive standard treatment including topical cream betamethasone thrice daily and Pentoxifylline tablet 400 mg twice daily. Group 2 will receive Metformin 500 mg thrice daily. Group 3 will receive topical cream metformin thrice daily. All groups will be instructed to perform a stick mouth opening exercise twice daily, alternating sides, holding the stick for 10 minutes on each side, with a 10-minute rest in between. All groups will be single blinded to the intervention.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'It would be a single-blind, placebo-controlled design', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-03-27