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

Not Applicable

Recruiting

• Conditions: Tinea Capitis
• Interventions: Drug: Terbinafine; Drug: Itraconazole

• Registration Number: NCT07068256
• Lead Sponsor: Muhammad Aamir Latif

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.

Study Timeline

• Study Start: 2025-04-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Terbinafine group	Terbinafine	Patients will be given terbinafine in a dose of 62.5 mg for less than 20 kg body weight, 125 mg from 20 to 40 kg, and 250 mg for more than 40 kg for a period of 4 weeks.
Itraconazole group	Itraconazole	Patients will receive itraconazole a dose of 5 mg/kg/day for 7 days and then 14 days off. Three such pulses will be given to the patients of this group.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Jinnah Hospital/Allama Iqbal Medical College; 🇵🇰 Lahore, Punjab, Pakistan