[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632096":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":51,"locations":61,"responsibleParty":82,"collaborators":29,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":29,"studyType":99,"phases":100,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":110,"whyStopped":29,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Tarumanagara University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","receives NB-UVB combined with microneedling and topical 10% secretome",[13],"Other: NB-UVB combined with microneedling and topical 10% secretome",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B","receives NB-UVB combined with intradermal secretome injection.",[18],"Other: receives NB-UVB combined with intradermal secretome injection",{"label":20,"type":10,"description":21,"interventionNames":22},"Group C","receives NB-UVB alone.",[23],"Drug: NB-UVB alone",[25,30,34],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"NB-UVB combined with microneedling and topical 10% secretome","Group A receives NB-UVB combined with microneedling and topical 10% secretome.",[9],null,{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"receives NB-UVB combined with intradermal secretome injection","Group B receives NB-UVB combined with intradermal secretome injection",[15],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"DRUG","NB-UVB alone","Group C receives NB-UVB alone",[20],[40,43,47],{"name":41,"affiliation":5,"role":42},"Sukmawati Tansil Tan","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":45,"role":46},"Yohanes Firmansyah","Universitas Tarumanagara","STUDY_DIRECTOR",{"name":48,"affiliation":49,"role":50},"Michael Jansen Politan","Precious Me Clinic","STUDY_CHAIR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":29,"email":56},"Sukmawati Tansil Tan, Dr.","CONTACT","+6287871111318","sukmawati@fk.untar.ac.id",{"name":58,"role":54,"phone":59,"phoneExt":29,"email":60},"Yohanes Firmansyah, MD","+6281297934375","yohanes@fk.untar.ac.id",[62],{"facility":63,"status":29,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Klinik Precious Me","Tangerang","Banten","11440","Indonesia","ID",{"type":70,"coordinates":71},"Point",[72,73],106.63,-6.17806,{"lat":73,"lon":72},[76,77,78,79],{"name":53,"role":54,"phone":55,"phoneExt":29,"email":56},{"name":58,"role":54,"phone":59,"phoneExt":29,"email":60},{"name":41,"role":42,"phone":29,"phoneExt":29,"email":29},{"name":80,"role":81,"phone":29,"phoneExt":29,"email":29},"YohaneS Firmansyah","SUB_INVESTIGATOR",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Yohanes Firmansyah, dr, MH, MM","Clinical officer","100632096","phase-2-comparative-efficacy-of-hucmsc-secretome-delivered-via-microneedling-and-intradermal-microinjection-as-adjuvant-therapy-to-nb-uvb-in-nonsegmental-vitiligo-a-quasi-experimental-study-100632096",false,"NCT07509242","Comparative Efficacy of hUCMSC-Secretome Delivered Via Microneedling and Intradermal Microinjection as Adjuvant Therapy to NB-UVB in Nonsegmental Vitiligo: A Quasi-Experimental Study","Vitiligo","Inclusion Criteria:\n\n* Patients with a diagnosis of non-segmental vitiligo (established by a dermatologist).\n* Age 18-60 years.\n* Fitzpatrick skin types III-V.\n* Stable vitiligo lesions for at least 6 months (no new lesions and no lesion expansion \\>10% of body surface area within the past 6 months).\n* Total lesion involvement of 1-20% body surface area (BSA).\n* Willing to comply with the full course of therapy and all scheduled follow-up visits during the study.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Segmental, universal, or other vitiligo types that are difficult to standardize (e.g., lesions limited to the genital area).\n* Currently receiving or having received within the past 3 months:\n* Systemic immunomodulatory or immunosuppressive therapy (e.g., systemic corticosteroids, cyclosporine, methotrexate, JAK inhibitors, etc.).\n\nOther phototherapy modalities (e.g., PUVA, excimer laser) within the past 3 months.\n\n* History of keloid formation or hypertrophic scarring at the treatment sites.\n* Active infection at the lesion sites (bacterial, viral, or fungal) or other skin diseases that may interfere with pigmentation assessment.\n* Pregnancy or breastfeeding.\n* History of skin cancer, lupus, or other photosensitive disorders.\n* Severe allergy to secretome components or gel excipients (if known).\n* Uncontrolled systemic diseases (e.g., heart failure, renal failure, active systemic autoimmune disease) that may compromise follow-up compliance.","ALL","18 Years","60 Years",{"count":97,"type":98},150,"ESTIMATED","INTERVENTIONAL",[101,102],"PHASE2","PHASE3","The goal of this clinical trial is to analyze the effectiveness of SM-hUCMSC secretome administered via microneedling and intradermal microinjection as adjuvant therapy to NB-UVB, compared with NB-UVB alone, in terms of repigmentation, onset of improvement, safety, patient satisfaction, and vitiligo recurrence. The main questions it aims to answer are:\n\n* Are there differences in the level of vitiligo lesion repigmentation among the secretome therapy via microneedling, intradermal microinjection, and NB-UVB phototherapy groups?\n* Are there differences in the time to onset of repigmentation among the treatment groups? What are the safety profiles and adverse events associated with each treatment modality?\n* Are there differences in patient satisfaction and quality of life after undergoing each therapy?\n* Are there differences in vitiligo recurrence rates during the follow-up period among the treatment groups?\n\nParticipants will be allocated into three groups as follows:\n\n* Group A receives NB-UVB combined with microneedling and topical 10% secretome.\n* Group B receives NB-UVB combined with intradermal secretome injection.\n* Group C receives NB-UVB alone. The intervention period lasts 12 weeks, with follow-up until week 24.",[91],[106,107,108,109,91],"Dermatology","Microneedling","NB-UVB","Secretome","NOT_YET_RECRUITING","2026-03-28",{"date":113,"type":114},"2026-04-03","ACTUAL",{"date":116,"type":98},"2026-03-18",{"date":118,"type":98},"2028-01-18",{"name":84,"class":6},1]