Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis

NCT07046988 | Recruiting DMC

• 1 other identifier: SDU-ZW-PPK-014
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Tinea Capitis

Outcome Measures

Primary Outcomes (5)

• Terbinafine concentration

  Terbinafine plasma concentration, terbinafine concentration in hair

  Through study completion, an average of 12 weeks.

• AUC

  Area under the curve (AUC)

  Through study completion, an average of 12 weeks.

• CL

  Clearance (CL)

  Through study completion, an average of 12 weeks.

• V

  Apparent volume of distribution (V)

  Through study completion, an average of 12 weeks.

• CV%

  Inter-individual variability (CV%) of AUC, CL and V with covariates

  Through study completion, an average of 12 weeks.

Secondary Outcomes (4)

• Clinical Efficacy

  The end of fellow-up, at 12 weeks

• Clinical Cure

  The end of fellow-up, at 12 weeks

• Mycological Cure

  The end of fellow-up, at 12 weeks

• Safety Assessment Indicators

  From enrollment to the end of treatment about 12 weeks

Interventions

Terbinafine Tablets DRUG

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.

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Chinese pediatric patients aged 2 to 18 years

You may qualify if:

• Aged 2 to 18 years;
• Diagnosis of tinea capitis:

You may not qualify if:

• 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;
• Participation in other clinical trials, or other circumstances deemed inappropriate by the investigator.

Sponsors & Collaborators

• Shandong University: lead
• Beijing Children's Hospital: collaborator

Study Sites (1)

Beijing Children's Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Tinea Capitis

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Scalp Dermatoses; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 2, 2025
• Study Start: June 15, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

CN (1)