Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Terbinafine Tablets.
- Who it may be relevant to
- Registry conditions: Tinea Capitis. Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Terbinafine Tablets
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.
Primary outcome measures
- Terbinafine concentration [Time frame: Through study completion, an average of 12 weeks.]
- AUC [Time frame: Through study completion, an average of 12 weeks.]
- CL [Time frame: Through study completion, an average of 12 weeks.]
- V [Time frame: Through study completion, an average of 12 weeks.]
- CV% [Time frame: Through study completion, an average of 12 weeks.]
Secondary outcome measures (4)
- Clinical Efficacy [Time frame: The end of fellow-up, at 12 weeks]
- Clinical Cure [Time frame: The end of fellow-up, at 12 weeks]
- Mycological Cure [Time frame: The end of fellow-up, at 12 weeks]
- Safety Assessment Indicators [Time frame: From enrollment to the end of treatment about 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Children's Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07046988 · SDU-ZW-PPK-014