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Recruiting Not applicable

Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment

NCT07331935 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-11-25
Last updated
2026-01-12

Condition(s) studied

Oral Leukoplakia

Investigational drug(s) / intervention(s)

Coenzyme Q10 gelTopical curcumin gel

Coenzyme Q10 gel: Application will be performed 2-3 times daily for 4 weeks.

Topical curcumin gel: Application will be performed 2-3 times daily for 4 weeks.

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in lesion size — baseline, 4 weeks, and 12 weeks
    measured clinically with a periodontal probe and/or digital images

Trial sites (1)

FacilityCityRegionStatus
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt Alexandria Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07331935 on ClinicalTrials.gov ↗ ← All trials in Egypt