Actively Recruiting
Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
Led by Shandong University · Updated on 2025-07-02
60
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
S
Shandong University
Lead Sponsor
B
Beijing Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 2 to 18 years
- Diagnosis of tinea capitis confirmed by typical symptoms, dermatoscopic findings with Wood's lamp examination
- Positive mycological exam including fungal microscopy and/or dermatophyte culture
- Exclusion of other scalp conditions such as seborrheic dermatitis, psoriasis, alopecia areata, lupus erythematosus, lichen planopilaris, trichotillomania, suppurative perifolliculitis, syphilitic alopecia
You will not qualify if you...
- Use of topical terbinafine treatment concurrently
- Conditions affecting gastrointestinal absorption of terbinafine
- Documented liver or kidney impairment or blood disorders
- Recent (within 2 weeks) radiotherapy or systemic cytostatic, immunosuppressive, antibacterial, antiviral, or antiparasitic therapy
- Participation in other clinical trials or deemed inappropriate by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Children's Hospital, Capital Medical University
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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