Tinea Capitis
Conditions
Keywords
Tinea Capitis
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.
Interventions
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.
Sponsors
Beijing Children's Hospital
Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CV% | Through study completion, an average of 12 weeks. | Inter-individual variability (CV%) of AUC, CL and V with covariates |
| Terbinafine concentration | Through study completion, an average of 12 weeks. | Terbinafine plasma concentration, terbinafine concentration in hair |
| 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) |
| V | Through study completion, an average of 12 weeks. | Apparent volume of distribution (V) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Outcome results
None listed