Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment

NCT07331935 | Recruiting

• 1 other identifier: 24092025
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Leukoplakia

Outcome Measures

Primary Outcomes (1)

• Change in lesion size

  measured clinically with a periodontal probe and/or digital images

  baseline, 4 weeks, and 12 weeks

Secondary Outcomes (1)

• Change in salivary markers

  baseline, 4 weeks, and 12 weeks

Study Arms (2)

Topical Coenzyme Q10 gel

EXPERIMENTAL

Other: Coenzyme Q10 gel

Topical curcumin gel

EXPERIMENTAL

Other: Topical curcumin gel

Interventions

Coenzyme Q10 gel OTHER

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

Topical Coenzyme Q10 gel

Topical curcumin gel OTHER

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

Topical curcumin gel

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Leukoplakia, Oral

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tasnim Saleem, BDS

CONTACT

010 28946295; tasneemsleem63@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 12, 2026
• Study Start: November 25, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

EG (1)