Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
ConditionTinea Capitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorShandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 2 to 18 years;
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.
Disqualifiers
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;
Trial population
Chinese pediatric patients aged 2 to 18 years
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Terbinafine Tablets
DrugOral 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Terbinafine concentration
Terbinafine plasma concentration, terbinafine concentration in hair
Time frame
Through study completion, an average of 12 weeks.2
AUC
Area under the curve (AUC)
Time frame
Through study completion, an average of 12 weeks.3
CL
Clearance (CL)
Time frame
Through study completion, an average of 12 weeks.4
V
Apparent volume of distribution (V)
Time frame
Through study completion, an average of 12 weeks.Secondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
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Shandong University
Lead sponsor
Beijing Children's Hospital
Collaborator
Source ClinicalTrials.gov