Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis

Launched by SHANDONG UNIVERSITY · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the medicine terbinafine, taken by mouth, behaves in children aged 2 to 18 who have tinea capitis, a fungal infection of the scalp. The researchers want to learn how the drug is processed in children’s bodies, how well it works to clear the infection, and whether it is safe to use in this group. They will also look at factors like age, weight, and kidney or liver function to see how these might affect the way the medicine works in different children.

Children who join the study will take terbinafine based on their weight, and their health will be carefully monitored through regular check-ups including scalp exams and lab tests to make sure the medicine is working and not causing problems. To join, children must have a confirmed diagnosis of tinea capitis and not be using other terbinafine treatments or have certain health issues that could affect the study. This study is currently looking for participants and aims to help doctors better understand how to treat scalp fungal infections in kids safely and effectively.

Gender

ALL

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.