NCT07046988 Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
| NCT ID | NCT07046988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shandong University |
| Condition | Tinea Capitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-06-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2021-06-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07046988 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Tinea Capitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07046988 currently recruiting?
Yes, NCT07046988 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shandong University to inquire about joining.
Where is the NCT07046988 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07046988 clinical trial?
NCT07046988 is sponsored by Shandong University. The trial plans to enroll 60 participants.