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RecruitingNCT07331935Updated Jan 12, 2026

Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment

An interventional study of Coenzyme Q10 gel and Topical curcumin gel in Oral Leukoplakia, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Nov 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

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.

02

Conditions studied

  • Oral Leukoplakia

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03

In context

Leukoplakia, Oral

42 studies on the registry are indexed under Leukoplakia, Oral; 10 are open to participants now.

This study's planned enrollment of 34 is close to the median of 35 across 22 interventional studies indexed under Leukoplakia, Oral.

Browse Leukoplakia, Oral studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Topical Coenzyme Q10 gel

    Other: Coenzyme Q10 gel

  • Experimental
    Topical curcumin gel

    Other: Topical curcumin gel

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.

06

What researchers measure

Primary outcomes

  1. Change in lesion size

    measured clinically with a periodontal probe and/or digital images

    Time frame: baseline, 4 weeks, and 12 weeks

Secondary outcomes

  1. Change in salivary markers

    Unstimulated whole saliva will be collected to assess salivary oxidative stress

    Time frame: baseline, 4 weeks, and 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
    Alexandria, Egypt
    • Faculty of Dentistry · Contact · (203) 4868308
    • Tasneem Saleem, BDS · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07331935
Lead sponsor
Alexandria University
Responsible party
Sponsor
First posted
Jan 12, 2026
Start date
Nov 25, 2025
Primary completion
Mar 30, 2026 (estimated)
Completion
Mar 30, 2026 (estimated)
Last update
Jan 12, 2026

Study contacts

Tasnim Saleem, BDS
Contact
tasneemsleem63@gmail.com
010 28946295 ext. 002

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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