Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coenzyme Q10 gel, Topical curcumin gel.
- Who it may be relevant to
- Registry conditions: Oral Leukoplakia. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- Other Coenzyme Q10 gel
Application will be performed 2-3 times daily for 4 weeks. - Other Topical curcumin gel
Application will be performed 2-3 times daily for 4 weeks.
Primary outcome measures
- Change in lesion size [Time frame: baseline, 4 weeks, and 12 weeks]
Secondary outcome measures (1)
- Change in salivary markers [Time frame: baseline, 4 weeks, and 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University — Alexandria
Identifiers
NCT: NCT07331935 · 24092025