[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634516":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":56,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Kasr El Aini Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Injectable Platelet-Rich Fibrin Side","EXPERIMENTAL","In this randomized split-face study, one side of each participant's face is randomly assigned to receive injectable platelet-rich fibrin (i-PRF). i-PRF is prepared from autologous venous blood and injected intradermally on the assigned side after topical anesthetic. Participants receive 5 treatment sessions at 2-week intervals.",[13],"Biological: Injectable Platelet-Rich Fibrin",{"label":15,"type":16,"description":17,"interventionNames":18},"Intradermal Tranexamic Acid Side","ACTIVE_COMPARATOR","In this randomized split-face study, the contralateral side of each participant's face receives intradermal tranexamic acid after topical anesthetic. Tranexamic acid is prepared under aseptic conditions and injected intradermally into melasma lesions. Participants receive 5 treatment sessions at 2-week intervals.",[19],"Drug: Tranexamic acid 100 mg\u002FmL (Kapron)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Injectable Platelet-Rich Fibrin","Injectable platelet-rich fibrin (i-PRF) is prepared from 10 mL of autologous venous blood collected in a plain plastic tube without additives and centrifuged at 60 g (700 rpm) for 3 minutes. The resulting fluid is aspirated immediately and injected intradermally on the randomized side of the face at a dose of 0.1 mL\u002Fcm² at 1-cm intervals using a 30-gauge insulin syringe. Five treatment sessions are administered at 2-week intervals.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Tranexamic acid 100 mg\u002FmL (Kapron)","Tranexamic acid (Kapron ampoules, 100 mg\u002FmL) is diluted under aseptic conditions to a final concentration of 10 mg\u002FmL by adding 0.1 mL of tranexamic acid to normal saline to a total volume of 1 mL. After topical anesthetic application, approximately 1 mL of the prepared 10 mg\u002FmL solution is injected intradermally into melasma lesions on the contralateral side of the face at 1-cm intervals using a 30-gauge insulin syringe. Five treatment sessions are administered at 2-week intervals.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Heba Ahmed","CONTACT","+201016532351","heba.a.abdelgayed@kasralainy.edu.eg",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Cairo","Cairo Governorate","11555","Egypt","EG",{"type":47,"coordinates":48},"Point",[49,50],31.24967,30.06263,{"lat":50,"lon":49},[53],{"name":54,"role":35,"phone":36,"phoneExt":26,"email":55},"Heba Ahmed, Lecturer of Dermatology","drhebaahmedyt@gmail.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","heba ahmed abdelgayed ibrahim","Lecturer of Dermatology","100634516","injectable-platelet-rich-fibrin-versus-intradermal-tranexamic-acid-for-melasma-100634516",false,"NCT07540702","Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma","Assessment of Efficacy and Safety of Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid in the Treatment of Melasma: A Randomized Split-Face Study","Inclusion Criteria:\n\n* Clinical diagnosis of bilateral symmetrical facial melasma (epidermal or mixed type)\n* Female participants aged 18 to 50 years\n* Fitzpatrick skin types III to IV\n* Mild to moderate facial melasma\n* No melasma-specific treatment within the previous 4 weeks\n* No facial procedures, including peeling, laser resurfacing, or microneedling, within the previous 3 months\n* Willing and able to provide written informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Bleeding or coagulation disorders\n* Use of anticoagulants, nonsteroidal anti-inflammatory drugs (NSAIDs), or hormonal contraception\n* Active skin infection or facial inflammation\n* History of keloids or Koebner-prone conditions, such as psoriasis or vitiligo\n* Uncontrolled systemic disease, such as diabetes mellitus or autoimmune disease","FEMALE","18 Years","50 Years",{"count":71,"type":72},21,"ESTIMATED","INTERVENTIONAL",[75],"NA","Melasma is a chronic acquired hyperpigmentation disorder that commonly affects the face and has a significant impact on quality of life. Available treatments may improve pigmentation, but relapse is common and response can be variable.\n\nThis randomized split-face interventional study aims to compare the efficacy and safety of injectable platelet-rich fibrin (i-PRF) versus intradermal tranexamic acid (TA) in the treatment of facial melasma. Adult female patients with bilateral symmetrical facial melasma will be enrolled. In each participant, one side of the face will be randomly assigned to receive i-PRF and the contralateral side will receive intradermal TA.\n\nPatients will undergo five treatment sessions at 2-week intervals. Clinical response will be assessed using the modified Melasma Area and Severity Index (mMASI), Antera 3D camera measurements, Physician Global Assessment, patient satisfaction, and Melasma Quality of Life (MelasQoL) questionnaire. Safety will be evaluated by recording adverse events such as pain, tenderness, erythema, swelling, infection, ecchymosis, and hematoma.\n\nThe study is designed to determine whether i-PRF is an effective and safe treatment option for melasma compared with intradermal tranexamic acid.",[78,79],"Melasma","Facial Melasma",[81,82,83,78,84],"Injectable platelet-rich fibrin","i-PRF","Tranexamic acid","Split-face study","2026-04-18",{"date":87,"type":88},"2026-04-22","ACTUAL",{"date":90,"type":88},"2026-02-01",{"date":92,"type":72},"2026-10-01",{"name":5,"class":6},1]