Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis

Recruiting

• Conditions: Tinea Capitis

• Registration Number: NCT07046988
• Lead Sponsor: Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Aged 2 to 18 years;

2. 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

1. Concomitant topical treatment with terbinafine;
2. Conditions interfering with gastrointestinal absorption of terbinafine;
3. Documented hepatic/renal impairment or hematological disorders;
4. Receipt of radiotherapy, systemic cytostatic/immunosuppressive therapy, or antibacterial/antiviral/antiparasitic therapy currently or within 2 weeks prior to study initiation;
5. Participation in other clinical trials, or other circumstances deemed inappropriate by the investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
V	Through study completion, an average of 12 weeks.	Apparent volume of distribution (V)
CV%	Through study completion, an average of 12 weeks.	Inter-individual variability (CV%) of AUC, CL and V with covariates
AUC	Through study completion, an average of 12 weeks.	Area under the curve (AUC)
CL	Through study completion, an average of 12 weeks.	Clearance (CL)
Terbinafine concentration	Through study completion, an average of 12 weeks.	Terbinafine plasma concentration, terbinafine concentration in hair

Secondary Outcome Measures

Name	Time	Method
Mycological Cure	The end of fellow-up, at 12 weeks	Defined as negative mycological examination results. Mycological cure rate = (number of mycologically cured cases / total cases) × 100%.
Safety Assessment Indicators	From enrollment to the end of treatment about 12 weeks	Drug-related adverse events and serious adverse events during the study.
Clinical Efficacy	The end of fellow-up, at 12 weeks	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.
Clinical Cure	The end of fellow-up, at 12 weeks	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.

Trial Locations

Locations (1)

Beijing Children's Hospital, Capital Medical University; 🇨🇳 Beijing, China