Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07046988

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Children's Hospital, Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Weiwei Jiao

CONTACT

[email protected]

+8613811970550

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 2 to 18 years;
  • 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

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Terbinafine concentration

    Time frame: Through study completion, an average of 12 weeks.

    Terbinafine plasma concentration, terbinafine concentration in hair

  2. AUC

    Time frame: Through study completion, an average of 12 weeks.

    Area under the curve (AUC)

  3. CL

    Time frame: Through study completion, an average of 12 weeks.

    Clearance (CL)

  4. V

    Time frame: Through study completion, an average of 12 weeks.

    Apparent volume of distribution (V)

  5. CV%

    Time frame: Through study completion, an average of 12 weeks.

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

Secondary outcomes

  1. Clinical Efficacy

    Time frame: 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.

  2. Clinical Cure

    Time frame: 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.

  3. Mycological Cure

    Time frame: 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%.

  4. Safety Assessment Indicators

    Time frame: From enrollment to the end of treatment about 12 weeks

    Drug-related adverse events and serious adverse events during the study.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Beijing Children's Hospital

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.