Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment

NCT ID: NCT07331935

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-25
• Study Completion Date: 2026-03-30

Brief Summary

Oral leukoplakia (OL) is recognized as the most common potentially malignant disorder of the oral mucosa. The pathogenesis of OL is complex and multifactorial, with oxidative stress playing a central role. Topical antioxidants have gained attention as therapeutic options to help stabilize lesions and potentially prevent malignant transformation. Both CoQ10 and curcumin have demonstrated a clinical success as strong antioxidants showing their capacity to reduce the lesion size and to stabilize the disease, ultimately preventing progression into oral malignancy. Aim: This study aims to clinically and biochemically assess the effectiveness of topical Coenzyme Q10 and Curcumin in the management of homogeneous oral leukoplakia.

Conditions

Oral Leukoplakia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Topical Coenzyme Q10 gel

Group Type: EXPERIMENTAL

Coenzyme Q10 gel

Intervention Type: OTHER

Application will be performed 2-3 times daily for 4 weeks.

Topical curcumin gel

Group Type: EXPERIMENTAL

Topical curcumin gel

Intervention Type: OTHER

Application will be performed 2-3 times daily for 4 weeks.

Interventions

Coenzyme Q10 gel

Application will be performed 2-3 times daily for 4 weeks.

Intervention Type: OTHER

Topical curcumin gel

Application will be performed 2-3 times daily for 4 weeks.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Tasnim Saleem, BDS

Role: CONTACT

tasneemsleem63@gmail.com

010 28946295 ext. 002

Facility Contacts

Faculty of Dentistry

Role: primary

(203) 4868308

Other Identifiers

24092025

Identifier Type: -

Identifier Source: org_study_id