Topical Coenzyme Q10 versus Curcumin for oral leukoplakia treatment

Clinical and Biochemical Assessment of the Effectivness of Topical Coenzyme Q10 and Topical Curcumin in Managment of Oral Leukoplakia (A Randomized Controlled Clinical Trial)

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

• Phase: NA
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Alexandria University (other)
• Locations: 1 site (Alexandria)
• Trial ID: NCT07331935 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Alexandria

• Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt — Alexandria, Egypt (RECRUITING)

Study contacts

• Study coordinator: Tasnim Saleem, BDS

Conditions: Oral Leukoplakia