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| Name | Class |
|---|---|
| Beijing Children's Hospital | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Aged 2 to 18 years;
Diagnosis of tinea capitis:
Exclusion Criteria:
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Chinese pediatric patients aged 2 to 18 years
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D014006 | Tinea Capitis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000077291 | Terbinafine |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 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 |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D012536 | Scalp Dermatoses |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |