Terbinafine dosing and blood levels in children with tinea capitis
Official title: Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
Run by Shandong University · NCT07046988 · Data updated 2026-11-12
This study will test how oral terbinafine is processed in children aged 2–18 with tinea capitis and whether the weight-based dosing is safe and effective.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | June 15, 2021 |
| Main results expected | December 31, 2025 |
| Study ends | June 1, 2026 |
| Registry record updated | July 2, 2025 |
| Trial ID | NCT07046988 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 2–18 years with a confirmed diagnosis of tinea capitis who are prescribed oral terbinafine and can attend scheduled blood sampling visits are ideal candidates.
✕Probably not a fit
Children with known hepatic or renal impairment, conditions affecting drug absorption, recent use of interacting systemic antimicrobials, or those using topical terbinafine are excluded and may not benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational population pharmacokinetic study enrolling Chinese children aged 2–18 who receive weight-based oral terbinafine for tinea capitis. Blood samples will be collected during routine treatment to measure terbinafine concentrations and derive PK parameters such as AUC, clearance, and volume of distribution. Investigators will model inter-individual variability and test covariates like age, body weight, CYP enzyme activity, and renal function to explain differences in drug disposition. Clinical outcomes (change in scalp severity score and mycological cure) and adverse events will be recorded to link exposure with safety and effectiveness.
Why it matters
Potential benefit: If successful, the results could help optimize terbinafine dosing in children to improve cure rates and reduce side effects.
How similar studies have gone: Adult terbinafine pharmacokinetics are well described, but pediatric population PK data are limited, so this approach is partly novel for children with tinea capitis.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Beijing Children's Hospital, Capital Medical University
Beijing, China Recruiting
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.