Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 1:46 AM
Study NCT ID:
NCT07331935
Status:
RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007972', 'term': 'Leukoplakia, Oral'}], 'ancestors': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007971', 'term': 'Leukoplakia'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-27', 'studyFirstSubmitDate': '2025-12-27', 'studyFirstSubmitQcDate': '2025-12-27', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lesion size', 'timeFrame': 'baseline, 4 weeks, and 12 weeks', 'description': 'measured clinically with a periodontal probe and/or digital images'}], 'secondaryOutcomes': [{'measure': 'Change in salivary markers', 'timeFrame': 'baseline, 4 weeks, and 12 weeks', 'description': 'Unstimulated whole saliva will be collected to assess salivary oxidative stress'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Leukoplakia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically and histologically diagnosed with homogeneous oral leukoplakia not indicated for surgical excision .\n* Lesions accessible for topical application.\n* Willing to sign informed consent and comply with study instructions and return to follow up\n\nExclusion Criteria:\n\n* Moderate-to-severe dysplasia, carcinoma in situ, or invasive oral cancer.\n* Presence of any visible oral lesions except for oral leukoplakia.\n* Active periodontal diseases as this can confound salivary biomarkers.\n* Significant systemic illness or immunosuppression.\n* Patients who have taken systemic or topical antioxidant supplements within the last four weeks will be excluded to avoid confounding effects on salivary biomarkers.\n* Pregnant and lactating women will be excluded due to hormonal changes that may alter oxidative stress and ethical considerations.\n* Patients unwilling or unable to comply with study requirements.'}, 'identificationModule': {'nctId': 'NCT07331935', 'briefTitle': 'Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Clinical and Biochemical Assessment of the Effectivness of Topical Coenzyme Q10 and Topical Curcumin in Managment of Oral Leukoplakia (A Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '24092025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical Coenzyme Q10 gel', 'interventionNames': ['Other: Coenzyme Q10 gel']}, {'type': 'EXPERIMENTAL', 'label': 'Topical curcumin gel', 'interventionNames': ['Other: Topical curcumin gel']}], 'interventions': [{'name': 'Coenzyme Q10 gel', 'type': 'OTHER', 'description': 'Application will be performed 2-3 times daily for 4 weeks.', 'armGroupLabels': ['Topical Coenzyme Q10 gel']}, {'name': 'Topical curcumin gel', 'type': 'OTHER', 'description': 'Application will be performed 2-3 times daily for 4 weeks.', 'armGroupLabels': ['Topical curcumin gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Faculty of Dentistry', 'role': 'CONTACT', 'phone': '(203) 4868308'}, {'name': 'Tasneem Saleem, BDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Tasnim Saleem, BDS', 'role': 'CONTACT', 'email': 'tasneemsleem63@gmail.com', 'phone': '010 28946295', 'phoneExt': '002'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}