[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622767":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":47,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Topical and systemic metformin","EXPERIMENTAL",null,[13],"Drug: Metformin Hydrochloride",{"label":15,"type":16,"description":11,"interventionNames":17},"Topical and systemic Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Metformin Hydrochloride","10% oral gel and 500mg tablet",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","Placebo Gel and 500mg Placebo tablet",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Mohamed Refaat Ghanem, MSc","CONTACT","+02 01221493237","Mohamed-Refaat@dentistry.cu.edu.eg",[36],{"facility":5,"status":37,"city":38,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":11},"RECRUITING","Cairo","Egypt","EG",{"type":42,"coordinates":43},"Point",[44,45],31.24967,30.06263,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Mohamed Refaat Elmohamady Soliman Ghanem","Principal Investigator","100622767","phase-2-evaluation-of-the-chemo-preventive-effect-of-combined-topical-and-systemic-metformin-on-oral-leukoplakia-100622767",false,"NCT07387900","Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia","Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Adult patients over 21 years.\n* Patients clinically diagnosed and histologically confirmed as having oral Leukoplakia.\n* Lesions with mild to moderate degree of dysplasia.\n* Patients who agree to sign a written consent after understanding the nature of the study.\n\nExclusion Criteria:\n\n* Patients with lesions showing sever degree of dysplasia.\n* Patients who have cardiovascular, lung, Renal, Liver diseases\n* Patients on metformin therapy (eg: Diabetes Mellitus, PCOS, …etc.)\n* Patients on H2 blocker \\& proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)\n* Those with allergy or sensitivity to Metformin therapy or having any contraindication for their use.\n* Patients on Retinoid, green tea supplements or another natural products therapy\n* Patients with other accompanying oral lesions\n* Pregnant or Lactating females","ALL","21 Years",{"count":61,"type":62},34,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Chemoprevention is a new direction in the management of OL using various topical and systemic agents such as; vitamin A, lycopene, celecoxib, green tea extract, and metformin.\n\nWhile metformin cannot realistically be used as cancer mono-therapy, it can be used as an adjunct and can have a more promising effect on lesions that have yet to undergo malignant transformation. Thus, the aim of this study is to investigate the efficacy of combined chemo-preventive effect of topical and systemic Metformin on oral leukoplakia.",[68],"Oral Leukoplakia",[68,70],"Metformin","2026-02-04",{"date":73,"type":74},"2026-02-06","ACTUAL",{"date":76,"type":62},"2026-02",{"date":78,"type":62},"2027-10",{"name":5,"class":6},1]