[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627421":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":40,"locations":30,"responsibleParty":46,"collaborators":30,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":30,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":30,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":73,"whyStopped":30,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":30},{"fullName":5,"class":6},"Assiut University","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined TXA + GSH-assisted microneedling arm","ACTIVE_COMPARATOR","will include 14 patients with facial melasma. They will be treated by combined\n\n* oral tranexamic acid (250 mg) twice a day for 3 months\n* microneedling assisted with glutathione every 4 weeks for a maximum of 3 months.",[13,14,15],"Device: microneedling","Drug: Oral tranexamic acid","Other: Glutathione",{"label":17,"type":10,"description":18,"interventionNames":19},"GSH-assisted microneedling arm","will include 14 patients, they will be treated by microneedling assisted with glutathione every 4 weeks for a maximum of 3 months.",[13,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Oral TXA","will include 14 patients, they will be treated by\n\n* oral TXA alone 250mg twice daily for a maximum of 3 months.",[14],[25,31,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","microneedling","with one ml of topical glutathione will be done in group A and B, three consecutive sessions, will be performed by derma pen with 36 needles head, will adjusted 1.5 mm needle length and will moved on stretched skin in four directions several times till erythema and pinpoint developed before and after topical application of GTH.",[9,17],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DRUG","Oral tranexamic acid","The patient will take oral tranexamic acid 250mg twice daily for 3 months",[9,21],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"Glutathione","investigators will use topical GSH solution in assist with microneedling to treat melasma",[9,17],[41],{"name":42,"role":43,"phone":44,"phoneExt":30,"email":45},"Rana Sameer, Postgraduate student","CONTACT","+201064123736","Ranasamer3344@gmail.com",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Rana Sameer Mohamed","Assistant lecturer","100627421","phase-2-evaluation-of-the-efficacy-of-oral-tranexamic-acid-and-glutathione-assisted-microneedling-in-treatment-of-melasma-100627421",false,"NCT07448415","Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma","Evaluation of the Efficacy and Safety of Oral Tranexamic Acid Combined With Glutathione-assisted Microneedling Versus Each Therapy Alone in the Treatment of Melasma","Inclusion Criteria:\n\n* • female patients\n\n  * 18\u002F50 years old\n  * facial melasma\n\nExclusion Criteria:\n\n* pregnancy\n* lactation.\n* History of any bleeding,\n* clotting disorder\n* using anticoagulants\n* Chronic systemic diseases\n* patients with history of atypical parkinsonism\n* use of neuroleptics,\n* history of a seizure\n* drug addiction\n* Patients with signs of facial inflammation or infection.\n* Patients on oral contraceptive pills\n* patients with hormonal replacement therapy\n* patients on isotretinoin at the time of the study or during the past 6 months.","FEMALE","18 Years","50 Years",{"count":61,"type":62},42,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE2","PHASE3","In this study, the investigators evaluate the potential efficacy of TXA alone and microneedling assisted with glutathione alone versus combination of oral tranexamic acid and glutathione-assisted microneedling in the treatment of melasma",[69],"Melasma",[71,72],"Tranexamic acid","glutathione","NOT_YET_RECRUITING","2026-02-28",{"date":76,"type":77},"2026-03-04","ACTUAL",{"date":79,"type":62},"2026-02",{"date":81,"type":62},"2027-04",{"name":5,"class":6}]