[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588514":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":37,"locations":25,"responsibleParty":43,"collaborators":25,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":25,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":25,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":25,"overallStatus":66,"whyStopped":25,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":25},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Micro-Needling Combined with Topical Treatments","EXPERIMENTAL","This arm involves 51 patients receiving four sessions of micro-needling across their entire face at four-week intervals. After micro-needling, topical ketotifen is applied to one half of the face and topical metformin to the other half. Between sessions, patients continue daily application of both treatments.",[13],"Device: Micro-Needling Combined with ketofin and metformin",{"label":15,"type":10,"description":16,"interventionNames":17},"topical Treatments Alone","This arm includes 51 patients receiving daily applications of topical ketotifen on one half of their face and topical metformin on the other half without undergoing micro-needling sessions.",[18],"Drug: ketofin and metformin Alone",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Micro-Needling Combined with ketofin and metformin","After micro-needling, topical ketotifen is applied to one half of the face and topical metformin to the other half. Between sessions, patients continue daily application of both treatments.",[9],null,{"type":27,"name":28,"description":16,"armGroupLabels":29,"otherNames":30},"DRUG","ketofin and metformin Alone",[15],[31],"topical treatments",[33],{"name":34,"affiliation":35,"role":36},"Radwa Bakr, Assistant professor","Assiot university","STUDY_DIRECTOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":25,"email":42},"Sara Khaled, Resident","CONTACT","01019420120","sarakhaled1098@gmail.com",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Sara Khaled AbdElAziz","resident at the dermatology department","100588514","phase-2-topical-metformin-versus-topical-ketotifen-in-melasma-treatment-100588514",false,"NCT06942390","Topical Metformin Versus Topical Ketotifen in Melasma Treatment","Topical Metfotmin Versus Topical Ketotifen (Alone or in Combination With Microneddling)in Melasma Treatment :Comparative Split Face Study","Inclusion Criteria:\n\n* Female adults of 18 years and above with bilateral melasma .\n* Clinical diagnosis of melasma.\n* Mental capacity to give informed consent.\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Current use of hormonal birth control medication or any hormonal therapy.\n* Current or previous treatment by depigmenting agents within 3 months\n* History of laser or MN to the face within 3 months of study enrollment.\n* Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar\u002Fkeloids.\n* Photosensitivity.\n* Patients with unrealistic expectations.","ALL","18 Years","60 Years",{"count":58,"type":59},60,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","The study aims to evaluate and compare the efficacy and safety of a new formulation of topical metformin (nanoparticles) versus topical ketotifen (nanoparticles), both alone and combined with micro-needling, for the treatment of melasma. It is a double-blinded, randomized, split-face controlled clinical study involving 102 female patients diagnosed with bilateral melasma.",[65],"Melasma","NOT_YET_RECRUITING","2025-04-16",{"date":69,"type":70},"2025-04-24","ACTUAL",{"date":72,"type":59},"2025-06-01",{"date":74,"type":59},"2026-10-30",{"name":5,"class":6}]