Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis

NCT ID: NCT07046988

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2026-06-01

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.

Conditions

Tinea Capitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Children's Hospital

OTHER

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Children's Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Weiwei Jiao

Role: primary

jiaowei310@163.com

+8613811970550

Other Identifiers

SDU-ZW-PPK-014

Identifier Type: -

Identifier Source: org_study_id