Could diabetes drug metformin help reverse mouth scarring?
NCT ID NCT06871904
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1/2 trial tested whether metformin (a diabetes drug) and pirfenidone (an anti-scarring drug) can reduce fibrosis in people with oral submucous fibrosis, a condition that causes mouth stiffness and raises cancer risk. 45 participants received either metformin, pirfenidone, or supportive care for 6 months. Researchers measured changes in mouth opening, pain, and molecular markers of scarring.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin and Pirfenidone
- What this could lead to
- If successful, this could provide an affordable, repurposed drug treatment for oral submucous fibrosis, reducing scarring and lowering cancer risk.
- What could go wrong
- This is an early-phase trial with only 45 participants, so results may not apply broadly. The drugs may cause side effects or fail to show significant improvement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
45 people
The number who actually took part.
- Started
-
Apr 2025
- Finished
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Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with OSF having fibrous bands 2. Patients with limited mouth opening due to OSF in Stage 2 and Stage 3 3. Patients who have not received any treatment for OSF in the previous three months 4. Patients with habits of pan, Chalia, Gutkha 5. The age group between 18 and 45 years Exclusion Criteria: 1. Patients presenting with OSCC 2. Patients with limited mouth opening due to impaction of the third molar 3. Patients with limited mouth opening due to temporomandibular joint disorder 4. Any history of Metformin intolerance or contraindications to its use. 5. Medical conditions (e.g., cardiovascular disease, renal/hepatic impairment) or drug therapy (\>6 months) with immunosuppressants, corticosteroids, or antifibrotics. 6. Pregnancy or lactation. 7. Participation in other clinical trials concurrently. 8. Inability / unwilling to provide informed written consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ziauddin University
Karachi, Sindh, 74700, Pakistan
More trials for these conditions
Other studies related to the condition(s) this trial covers.