Efficacy Comparison of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Children.

Comparison Between Therapeutic Efficacy of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Pediatric Population.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07068256

Enrollment

164

Registered

2025-07-16

Start date

2025-04-01

Completion date

2025-09-30

Last updated

2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinea Capitis

Brief summary

Several studies globally have assessed the efficacy of terbinafine and itraconazole in the treatment of tinea capitis, but local data in this regard is scarce. Therefore, this study was planned with the aim of assessing the difference between the therapeutic efficacy of itraconazole pulse therapy and terbinafine in children with tinea capitis.

Detailed description

The existing literature carries varying results between the effectiveness of itraconazole pulse therapy and continuous terbinafine therapy in treating tinea capitis, and local data in this regard is also scarce. The findings of this study would not only add to the statistics but would also help clinicians to offer a treatment modality in pediatric tinea capitis, which should have better efficacy, a low incidence of side effects, and better patient compliance.

Interventions

DRUGTerbinafine

Terbinafine will be given at a dose of 62.5 mg in patients with a body weight \< 20 kg, 125 mg from 20 to 40 kg, and 250 mg in \> 40 kg for a period of 4 weeks.

DRUGItraconazole

Itraconazole will be given at a dose of 5 mg/kg/day for 7 days and then 14 days off. Three such pulses will be given to the patients.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 13 Years

Healthy volunteers

Inclusion criteria

* Any gender * Aged 1-13 years * With KOH mount positive before start of treatment * Duration of disease more than 1 month

Exclusion criteria

* KOH mount negative before starting the treatment * Topical treatment with antifungal agents within past 4 weeks * Systemic treatment with antifungal agents within past 4 weeks * Patients with active liver disease * Patients with elevated liver enzymes

Design outcomes

Primary

Measure	Time frame	Description
Fungus eradication	9 weeks	Treatment will be labeled efficacious if the patient will be cured clinically as well as mycologically, i.e., samples treated with KOH will show no fungal elements.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026