[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585316":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Xijing Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tacrolimus Treatment Group","EXPERIMENTAL","Participants in this arm receive oral tacrolimus therapy following the specified dosage and administration schedule in the study protocol for treating rapidly progressive vitiligo in children.",[13],"Drug: Tacrolimus",{"label":15,"type":16,"description":17,"interventionNames":18},"Dexamethasone Comparison Group","ACTIVE_COMPARATOR","Participants in this arm receive oral dexamethasone as the comparative intervention, administered according to the study protocol for evaluating its efficacy and safety in treating rapidly progressive vitiligo in children.",[19],"Drug: Dexamethasone",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tacrolimus","Participants receive oral tacrolimus capsules at a dosage of 0.1 ± 0.05 mg\u002Fkg per day, divided into two administrations. The treatment duration is 24 weeks. Blood drug concentration is monitored to maintain trough levels between 7-15 ng\u002FmL. Safety assessments include regular blood tests (hematology, liver\u002Fkidney function, blood glucose) and adverse event tracking.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Dexamethasone","Participants receive oral dexamethasone tablets at a dosage of 0.05 ± 0.025 mg\u002Fkg per day, administered as a single dose on weekends (Saturday and Sunday). The treatment duration is 24 weeks. Safety evaluations include monitoring of blood parameters (hematology, liver\u002Fkidney function, blood glucose), weight, and adrenal function (cortisol, ACTH levels).",[15],[32],{"name":33,"affiliation":34,"role":35},"Zhe Jian, Associate Professor","First Affiliated Hospital of Air Force Medical University","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+862984775406","13571826086@163.com",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Xi'an","Shaanxi","710032","China","CN",{"type":50,"coordinates":51},"Point",[52,53],108.92861,34.25833,{"lat":53,"lon":52},[56,57],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":58,"role":38,"phone":59,"phoneExt":26,"email":60},"Yucheng Sun","+8618215408401","814572592@qq.com",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100585316","oral-tacrolimus-vs-dexamethasone-micro-pulse-therapy-in-pediatric-rapidly-progressing-vitiligo-a-multicenter-rct-100585316",false,"NCT06900777","Oral Tacrolimus vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: A Multicenter RCT","Oral Tacrolimus Capsule Versus Dexamethasone Micro-pulse Therapy for the Treatment of Rapidly Progressing Vitiligo in Children: A Multicenter, Randomized, Controlled Study","Inclusion Criteria:\n\n* Children aged 4-12 years diagnosed with rapidly progressive non-segmental vitiligo (VIDA score ≥4, indicating disease progression within the past 6 weeks).\n\nTotal body surface area (BSA) affected by vitiligo between 1% and 50%. Guardians provide written informed consent for the child's participation.\n\nExclusion Criteria:\n\n* Stable-phase childhood vitiligo. Segmental, mucosal, undetermined, or generalized vitiligo. Systemic immunosuppressive therapy within the past 4 weeks. Known hypersensitivity to tacrolimus, other macrolide drugs, or study drug excipients.\n\nComorbidities precluding oral tacrolimus use (e.g., severe hepatic\u002Frenal dysfunction).\n\nObesity or systemic diseases (e.g., tuberculosis, acute\u002Fchronic infections, hypertension, congenital cardiovascular disease).\n\nAny condition deemed by investigators to increase participant risk or interfere with trial execution.","ALL","4 Years","12 Years",{"count":74,"type":75},90,"ESTIMATED","INTERVENTIONAL",[78],"NA","This clinical study aims to compare the safety and effectiveness of two treatments-oral Tacrolimus capsules and Dexamethasone micro-pulse therapy-in children aged 4-12 years with rapidly progressing vitiligo. The study is a multicenter, randomized, controlled trial involving 90 participants, who will be divided equally into two groups. One group will receive daily Tacrolimus, while the other will take Dexamethasone on weekends. Over 24 weeks, doctors will monitor improvements in skin repigmentation, side effects, and overall health through regular check-ups and blood tests. The goal is to determine which treatment better controls disease progression and improves quality of life for children with vitiligo.\n\nKey Points:\n\n* For children with rapidly spreading vitiligo.\n* Compares two common medications.\n* Follows participants for 6 months.\n* Focuses on safety and effectiveness.",[81,82,83],"Vitiligo","Child","Progressive Disease",[23,28,85,86,81,87,88,89,90,91,92],"Randomized Controlled Trialy","Children","Safety","Efficacy","Multicenter Study","VASI Score","IGA Score","Immunosuppressive Therapy","2025-06-16",{"date":95,"type":96},"2025-06-19","ACTUAL",{"date":98,"type":96},"2025-04-01",{"date":100,"type":75},"2026-04-01",{"name":5,"class":6},1]