Topical Coenzyme Q10 versus Curcumin for oral leukoplakia treatment
Official title: Clinical and Biochemical Assessment of the Effectivness of Topical Coenzyme Q10 and Topical Curcumin in Managment of Oral Leukoplakia (A Randomized Controlled Clinical Trial)
Run by Alexandria University · NCT07331935 · Data updated 2026-11-12
This trial will test whether applying Coenzyme Q10 or curcumin gels directly to homogeneous oral leukoplakia lesions helps shrink or stabilize them in patients who do not need surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Status | Recruiting |
| Started | November 25, 2025 |
| Main results expected | March 30, 2026 |
| Study ends | March 30, 2026 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT07331935 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with clinically and histologically confirmed homogeneous oral leukoplakia that is not indicated for surgical excision and whose lesions are accessible for topical application.
✕Probably not a fit
Patients with moderate-to-severe dysplasia, carcinoma in situ or invasive oral cancer, multiple or other visible oral lesions, active periodontal disease, recent antioxidant use, pregnancy, or major systemic illness are unlikely to benefit from this topical intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study will enroll patients with clinically and histologically confirmed homogeneous oral leukoplakia whose lesions are accessible for topical application. Participants will apply a topical CoQ10 gel or a topical curcumin gel according to the study protocol and return for scheduled follow-up visits. Investigators will record clinical outcomes such as lesion size and appearance and collect salivary samples to measure oxidative stress–related biomarkers. Key exclusions include moderate-to-severe dysplasia or cancer, other visible oral lesions, recent antioxidant use, active periodontal disease, pregnancy or significant systemic illness to avoid confounding results.
Why it matters
Potential benefit: If successful, topical CoQ10 or curcumin could reduce lesion size and help stabilize oral leukoplakia, potentially lowering the risk of progression to oral cancer.
How similar studies have gone: Small clinical reports and pilot studies have suggested topical curcumin and CoQ10 can reduce lesion size and oxidative stress markers, but larger controlled trials are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically and histologically diagnosed with homogeneous oral leukoplakia not indicated for surgical excision . * Lesions accessible for topical application. * Willing to sign informed consent and comply with study instructions and return to follow up Exclusion Criteria: * Moderate-to-severe dysplasia, carcinoma in situ, or invasive oral cancer. * Presence of any visible oral lesions except for oral leukoplakia. * Active periodontal diseases as this can confound salivary biomarkers. * Significant systemic illness or immunosuppression. * Patients who have taken systemic or topical antioxidant supplements within the last four weeks will be excluded to avoid confounding effects on salivary biomarkers. * Pregnant and lactating women will be excluded due to hormonal changes that may alter oxidative stress and ethical considerations. * Patients unwilling or unable to comply with study requirements.
Where it's running
-
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Egypt Recruiting
Study contacts
- Study coordinator: Tasnim Saleem, BDS
- Email: tasneemsleem63@gmail.com
- Phone: 010 28946295
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.