NCT07387900 Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
| NCT ID | NCT07387900 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cairo University |
| Condition | Oral Leukoplakia |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2026-02 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 34 participants in total. It began in 2026-02 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07387900 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Oral Leukoplakia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07387900 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07387900 currently recruiting?
Yes, NCT07387900 is actively recruiting participants. Contact the research team at Mohamed-Refaat@dentistry.cu.edu.eg for enrollment information.
Where is the NCT07387900 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07387900 clinical trial?
NCT07387900 is sponsored by Cairo University. The trial plans to enroll 34 participants.