Efficacy of Topical Coenzyme Q10 and 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)

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07331935

Enrollment

Registered

2026-01-12

Start date

2025-11-25

Completion date

2026-03-30

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Leukoplakia

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.

Interventions

OTHERCoenzyme Q10 gel

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

OTHERTopical curcumin gel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in lesion size	baseline, 4 weeks, and 12 weeks	measured clinically with a periodontal probe and/or digital images

Secondary

Measure	Time frame	Description
Change in salivary markers	baseline, 4 weeks, and 12 weeks	Unstimulated whole saliva will be collected to assess salivary oxidative stress

Countries

Egypt

Contacts

Primary ContactTasnim Saleem, BDS

tasneemsleem63@gmail.com010 28946295

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026