[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596555":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":44,"armGroups":40,"interventions":45,"overallOfficials":40,"centralContacts":40,"locations":50,"responsibleParty":69,"collaborators":73,"id":76,"slug":40,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":40,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":87,"studyType":88,"phases":40,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":53,"whyStopped":40,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Shandong University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":40},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Terbinafine concentration","Terbinafine plasma concentration, terbinafine concentration in hair","Through study completion, an average of 12 weeks.",{"measure":14,"description":15,"timeFrame":12},"AUC","Area under the curve (AUC)",{"measure":17,"description":18,"timeFrame":12},"CL","Clearance (CL)",{"measure":20,"description":21,"timeFrame":12},"V","Apparent volume of distribution (V)",{"measure":23,"description":24,"timeFrame":12},"CV%","Inter-individual variability (CV%) of AUC, CL and V with covariates",[26,30,33,36],{"measure":27,"description":28,"timeFrame":29},"Clinical Efficacy","Defined as a 60-99% reduction in TSSS compared to baseline. Values below 60% are considered ineffective.\n\nClinical efficacy rate = (number of effective cases \u002F total cases) × 100%. TSSS is a scale scoring the severity of 5 signs and symptoms (erythema, desquamation\u002Fscaling, papules, pustules, and pruritus) into 4 grades (0 = none; 1 = mild; 2 = moderate; 3 = severe). The sum of these scores yields TSSS, with a maximum of 15 points.","The end of fellow-up, at 12 weeks",{"measure":31,"description":32,"timeFrame":29},"Clinical Cure","Defined as 100% efficacy (TSSS = 0). Clinical cure rate = (number of clinically cured cases \u002F total cases) × 100%. TSSS is a scale scoring the severity of 5 signs and symptoms (erythema, desquamation\u002Fscaling, papules, pustules, and pruritus) into 4 grades (0 = none; 1 = mild; 2 = moderate; 3 = severe). The sum of these scores yields TSSS, with a maximum of 15 points.",{"measure":34,"description":35,"timeFrame":29},"Mycological Cure","Defined as negative mycological examination results. Mycological cure rate = (number of mycologically cured cases \u002F total cases) × 100%.",{"measure":37,"description":38,"timeFrame":39},"Safety Assessment Indicators","Drug-related adverse events and serious adverse events during the study.","From enrollment to the end of treatment about 12 weeks",null,{"allocation":40,"interventionModel":40,"interventionModelDescription":40,"primaryPurpose":40,"observationalModel":42,"timePerspective":43,"maskingInfo":40},"COHORT","PROSPECTIVE","Chinese pediatric patients aged 2 to 18 years",[46],{"type":47,"name":48,"description":49,"armGroupLabels":40,"otherNames":40},"DRUG","Terbinafine Tablets","Oral administration once daily:\n\nFor patients weighing \\\u003C20 kg: 62.5 mg qd; For patients weighing 20-40 kg: 125 mg qd; For patients weighing \\>40 kg: 250 mg qd; Total 8 weeks.",[51],{"facility":52,"status":53,"city":54,"state":40,"zip":40,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Beijing Children's Hospital, Capital Medical University","RECRUITING","Beijing","China","CN",{"type":58,"coordinates":59},"Point",[60,61],116.39723,39.9075,{"lat":61,"lon":60},[64],{"name":65,"role":66,"phone":67,"phoneExt":40,"email":68},"Weiwei Jiao","CONTACT","+8613811970550","jiaowei310@163.com",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Wei Zhao","Head of department of clinical pharmacy and pharmacology",[74],{"name":75,"class":6},"Beijing Children's Hospital","100596555",false,"NCT07046988","Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis","Inclusion Criteria:\n\n1. Aged 2 to 18 years;\n2. Diagnosis of tinea capitis:\n\n   * Typical clinical manifestations, dermatoscopic findings combined with Wood's lamp examination; ② Positive mycological examination, including positive fungal microscopy and\u002For isolation of dermatophytes by fungal culture; ③ Exclusion of scalp seborrheic dermatitis, psoriasis, alopecia areata, lupus erythematosus, lichen planopilaris, trichotillomania, suppurative perifolliculitis of scalp, syphilitic alopecia, etc.\n\nExclusion Criteria:\n\n1. Concomitant topical treatment with terbinafine;\n2. Conditions interfering with gastrointestinal absorption of terbinafine;\n3. Documented hepatic\u002Frenal impairment or hematological disorders;\n4. Receipt of radiotherapy, systemic cytostatic\u002Fimmunosuppressive therapy, or antibacterial\u002Fantiviral\u002Fantiparasitic therapy currently or within 2 weeks prior to study initiation;\n5. Participation in other clinical trials, or other circumstances deemed inappropriate by the investigator.","ALL","2 Years","18 Years",{"count":85,"type":86},60,"ESTIMATED","4 Weeks","OBSERVATIONAL","The goal of this observational study is to characterize the population pharmacokinetics (PPK) of terbinafine in pediatric patients with tinea capitis, evaluate its efficacy and safety, and identify covariates affecting drug disposition in Chinese children aged 2-18 years diagnosed with tinea capitis and treated with oral terbinafine. The main questions it aims to answer are:\n\nWhat are the terbinafine pharmacokinetic parameters (e.g., AUC, CL, V) in children with tinea capitis, and how do they differ from adult values? Which covariates (e.g., age, body weight, CYP enzyme activity, renal function) significantly influence inter-individual variability in terbinafine PK parameters? What is the clinical efficacy (based on TSSS reduction and mycological cure rate) and safety profile of terbinafine in this pediatric population?\n\nParticipants will:\n\nUndergo oral terbinafine treatment according to weight-based dosing (62.5-250 mg daily).\n\nConcentration determination is carried out using the opportunistic sampling method.\n\nComplete clinical assessments (TSSS scoring) and mycological examinations (microscopy\u002Fculture) at baseline and follow-up visits.\n\nUndergo routine laboratory tests (liver\u002Fkidney function, hematology) to monitor safety.",[91],"Tinea Capitis",[91],"2025-06-30",{"date":95,"type":96},"2025-07-02","ACTUAL",{"date":98,"type":96},"2021-06-15",{"date":100,"type":86},"2026-06-01",{"name":5,"class":6},1]