Oral LeukoplakiaNCT07331935
Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment
A study testing Coenzyme Q10 gel and Topical curcumin gel in people with Oral Leukoplakia, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Oral Leukoplakia
- What is being tested?
- Coenzyme Q10 gel and Topical curcumin gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
Faculty of Dentistry, (203) 4868308
Tasneem Saleem, BDS
About this study
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)
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.
- Conditions
- Oral Leukoplakia
- Being tested
- Coenzyme Q10 gel, Topical curcumin gel
- Medical subject headings
- Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10 gelOther
Application will be performed 2-3 times daily for 4 weeks.
Topical curcumin gelOther
Application will be performed 2-3 times daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Topical Coenzyme Q10 gel | Experimental | Not described Receives: Other: Coenzyme Q10 gel |
| Topical curcumin gel | Experimental | Not described Receives: Other: Topical curcumin gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lesion size
measured clinically with a periodontal probe and/or digital images
Measured: baseline, 4 weeks, and 12 weeks
Secondary outcomes (1)
Change in salivary markers
Unstimulated whole saliva will be collected to assess salivary oxidative stress
Measured: baseline, 4 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start25 Nov 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral LeukoplakiaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331935
- Sponsor's protocol ID
- 24092025
- Status last verified
- Dec 2025
- First submitted
- 27 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07331935
- Acronym / sponsor ID
- 24092025
- Conditions
- Oral Leukoplakia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Coenzyme Q10 gel | Experimental | Other: Coenzyme Q10 gel |
| Topical curcumin gel | Experimental | Other: Topical curcumin gel |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10 gelApplication will be performed 2-3 times daily for 4 weeks. | Other | Topical Coenzyme Q10 gel |
| Topical curcumin gelApplication will be performed 2-3 times daily for 4 weeks. | Other | Topical curcumin gel |
Primary outcome
Change in lesion size
Time frame: baseline, 4 weeks, and 12 weeks
measured clinically with a periodontal probe and/or digital images
1 secondary outcome
Change in salivary markers
Time frame: baseline, 4 weeks, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 gel and Topical curcumin gel in people with Oral Leukoplakia, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tasnim Saleem, BDS (010 28946295 ext. 002, tasneemsleem63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lesion size (time frame: baseline, 4 weeks, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.