Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis (NCT07046988) | Clinical Trial Compass
RecruitingNot Applicable
Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
China60 participantsStarted 2021-06-15
Plain-language summary
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.
Who can participate
Age range
2 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 2 to 18 years;
. Diagnosis of tinea capitis:
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Terbinafine concentration
Timeframe: Through study completion, an average of 12 weeks.
2
AUC
Timeframe: Through study completion, an average of 12 weeks.
3
CL
Timeframe: Through study completion, an average of 12 weeks.
4
V
Timeframe: Through study completion, an average of 12 weeks.
5
CV%
Timeframe: Through study completion, an average of 12 weeks.