Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment

December 27, 2025 updated by: Alexandria University

Clinical and Biochemical Assessment of the Effectivness of Topical Coenzyme Q10 and Topical Curcumin in Managment of Oral Leukoplakia (A Randomized Controlled Clinical Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
        • Contact:
          • Faculty of Dentistry
          • Phone Number: (203) 4868308
        • Principal Investigator:
          • Tasneem Saleem, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical Coenzyme Q10 gel
Other: Coenzyme Q10 gel
Application will be performed 2-3 times daily for 4 weeks.
Experimental: Topical curcumin gel
Other: Topical curcumin gel
Application will be performed 2-3 times daily for 4 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

December 27, 2025

First Submitted That Met QC Criteria

December 27, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 27, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24092025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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