Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment

Alexandria University

Status

Enrolling

Conditions

Oral Leukoplakia

Treatments

Other: Coenzyme Q10 gel

Other: Topical curcumin gel

Study type

Interventional

Funder types

Other

Identifiers

NCT07331935

24092025

Details and patient eligibility

About

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.

Enrollment

34 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.