Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis

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.

Study Overview

• Status: Recruiting
• Conditions: Tinea Capitis
• Intervention / Treatment: Drug: Terbinafine Tablets

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Children's Hospital, Capital Medical University
    • Contact: Weiwei Jiao; Phone Number: +8613811970550; Email: jiaowei310@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chinese pediatric patients aged 2 to 18 years

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Beijing Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: June 30, 2025
• First Posted (Actual): July 2, 2025

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Tinea Capitis
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatomycoses; Scalp Dermatoses; Tinea; Tinea Capitis; Anti-Infective Agents; Antifungal Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Terbinafine
• Other Study ID Numbers: SDU-ZW-PPK-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No