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: What 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? Participants will: Undergo oral terbinafine treatment according to weight-based dosing (62.5-250 mg daily). Concentration determination is carried out using the opportunistic sampling method. Complete clinical assessments (TSSS scoring) and mycological examinations (microscopy/culture) at baseline and follow-up visits. Undergo routine laboratory tests (liver/kidney function, hematology) to monitor safety.
Study Type
OBSERVATIONAL
Enrollment
60
Oral administration once daily: For patients weighing \<20 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.
Beijing Children's Hospital, Capital Medical University
Beijing, China
RECRUITINGTerbinafine concentration
Terbinafine plasma concentration, terbinafine concentration in hair
Time frame: Through study completion, an average of 12 weeks.
AUC
Area under the curve (AUC)
Time frame: Through study completion, an average of 12 weeks.
CL
Clearance (CL)
Time frame: Through study completion, an average of 12 weeks.
V
Apparent volume of distribution (V)
Time frame: Through study completion, an average of 12 weeks.
CV%
Inter-individual variability (CV%) of AUC, CL and V with covariates
Time frame: Through study completion, an average of 12 weeks.
Clinical Efficacy
Defined as a 60-99% reduction in TSSS compared to baseline. Values below 60% are considered ineffective. Clinical efficacy rate = (number of effective cases / total cases) × 100%. TSSS is a scale scoring the severity of 5 signs and symptoms (erythema, desquamation/scaling, 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.
Time frame: The end of fellow-up, at 12 weeks
Clinical Cure
Defined as 100% efficacy (TSSS = 0). Clinical cure rate = (number of clinically cured cases / total cases) × 100%. TSSS is a scale scoring the severity of 5 signs and symptoms (erythema, desquamation/scaling, 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.
Time frame: The end of fellow-up, at 12 weeks
Mycological Cure
Defined as negative mycological examination results. Mycological cure rate = (number of mycologically cured cases / total cases) × 100%.
Time frame: The end of fellow-up, at 12 weeks
Safety Assessment Indicators
Drug-related adverse events and serious adverse events during the study.
Time frame: From enrollment to the end of treatment about 12 weeks
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