Oral LeukoplakiaPhase 2NCT07387900
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
A Phase 2 study testing Metformin Hydrochloride in people with Oral Leukoplakia, run by Cairo University at 1 site in Egypt.
Trial summary
There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Oral Leukoplakia
- What is being tested?
- Metformin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 21 years.
- Patients clinically diagnosed and histologically confirmed as having oral Leukoplakia.
- Lesions with mild to moderate degree of dysplasia.
- Patients who agree to sign a written consent after understanding the nature of the study.
Who cannot join
- Patients with lesions showing sever degree of dysplasia.
- Patients who have cardiovascular, lung, Renal, Liver diseases
- Patients on metformin therapy (eg: Diabetes Mellitus, PCOS, …etc.)
- Patients on H2 blocker \& proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)
- Those with allergy or sensitivity to Metformin therapy or having any contraindication for their use.
- Patients on Retinoid, green tea supplements or another natural products therapy
- Patients with other accompanying oral lesions
- Pregnant or Lactating females
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial
There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Chemoprevention is a new direction in the management of OL using various topical and systemic agents such as; vitamin A, lycopene, celecoxib, green tea extract, and metformin.
While metformin cannot realistically be used as cancer mono-therapy, it can be used as an adjunct and can have a more promising effect on lesions that have yet to undergo malignant transformation. Thus, the aim of this study is to investigate the efficacy of combined chemo-preventive effect of topical and systemic Metformin on oral leukoplakia.
- Conditions
- Oral Leukoplakia
- Being tested
- Metformin Hydrochloride, Placebo
- Keywords
- Oral Leukoplakia, Metformin
- Medical subject headings
- Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin HydrochlorideDrug
10% oral gel and 500mg tablet
PlaceboDrug
Placebo Gel and 500mg Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Topical and systemic metformin | Experimental | Not described Receives: Drug: Metformin Hydrochloride |
| Topical and systemic Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lesion size
the lesion will be measured in size by periodontal probe bi-dimensionally in mms
Measured: over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral LeukoplakiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Refaat Elmohamady Soliman Ghanem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387900
- Sponsor's protocol ID
- OMED 3.7.2
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07387900
- Acronym / sponsor ID
- OMED 3.7.2
- Conditions
- Oral Leukoplakia
- Keywords
- Oral Leukoplakia, Metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Chemoprevention is a new direction in the management of OL using various topical and systemic agents such as; vitamin A, lycopene, celecoxib, green tea extract, and metformin.
While metformin cannot realistically be used as cancer mono-therapy, it can be used as an adjunct and can have a more promising effect on lesions that have yet to undergo malignant transformation. Thus, the aim of this study is to investigate the efficacy of combined chemo-preventive effect of topical and systemic Metformin on oral leukoplakia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical and systemic metformin | Experimental | Drug: Metformin Hydrochloride |
| Topical and systemic Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients over 21 years.
- Patients clinically diagnosed and histologically confirmed as having oral Leukoplakia.
- Lesions with mild to moderate degree of dysplasia.
- Patients who agree to sign a written consent after understanding the nature of the study.
Key exclusion criteria (8 listed)
- Patients with lesions showing sever degree of dysplasia.
- Patients who have cardiovascular, lung, Renal, Liver diseases
- Patients on metformin therapy (eg: Diabetes Mellitus, PCOS, …etc.)
- Patients on H2 blocker \& proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)
- Those with allergy or sensitivity to Metformin therapy or having any contraindication for their use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin Hydrochloride10% oral gel and 500mg tablet | Drug | Topical and systemic metformin |
| PlaceboPlacebo Gel and 500mg Placebo tablet | Drug | Topical and systemic Placebo |
Primary outcome
Change in lesion size
Time frame: over 6 months
the lesion will be measured in size by periodontal probe bi-dimensionally in mms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
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Pembrolizumab in Treating Participants With Leukoplakia
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Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
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Enrolling by invitation
The Importance of Mucosal Screening in the Prevention of Oral Cancer.
OPMD, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin Hydrochloride in people with Oral Leukoplakia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Refaat Ghanem, MSc (+02 01221493237, Mohamed-Refaat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lesion size (time frame: over 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.