Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- V
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 2 to 18 years;
- •Diagnosis of tinea capitis:
- •Typical clinical manifestations, dermatoscopic findings combined with Wood's lamp examination; ② Positive mycological examination, including positive fungal microscopy and/or 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.
排除标准
- •Concomitant topical treatment with terbinafine;
- •Conditions interfering with gastrointestinal absorption of terbinafine;
- •Documented hepatic/renal impairment or hematological disorders;
- •Receipt of radiotherapy, systemic cytostatic/immunosuppressive therapy, or antibacterial/antiviral/antiparasitic therapy currently or within 2 weeks prior to study initiation;
- •Participation in other clinical trials, or other circumstances deemed inappropriate by the investigator.
结局指标
主要结局
V
时间窗: Through study completion, an average of 12 weeks.
Apparent volume of distribution (V)
CV%
时间窗: Through study completion, an average of 12 weeks.
Inter-individual variability (CV%) of AUC, CL and V with covariates
AUC
时间窗: Through study completion, an average of 12 weeks.
Area under the curve (AUC)
CL
时间窗: Through study completion, an average of 12 weeks.
Clearance (CL)
Terbinafine concentration
时间窗: Through study completion, an average of 12 weeks.
Terbinafine plasma concentration, terbinafine concentration in hair
次要结局
- Mycological Cure(The end of fellow-up, at 12 weeks)
- Safety Assessment Indicators(From enrollment to the end of treatment about 12 weeks)
- Clinical Efficacy(The end of fellow-up, at 12 weeks)
- Clinical Cure(The end of fellow-up, at 12 weeks)
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University