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

NCT ID: NCT07068256

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-09-30

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.

Conditions

Tinea Capitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Terbinafine group

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.

Group Type: EXPERIMENTAL

Terbinafine

Intervention Type: DRUG

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.

Itraconazole group

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.

Group Type: EXPERIMENTAL

Itraconazole

Intervention Type: DRUG

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.

Interventions

Terbinafine

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.

Intervention Type: DRUG

Itraconazole

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhammad Aamir Latif

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Aamir Latif

Research Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Saima Aslam

Role: PRINCIPAL_INVESTIGATOR

Jinnah Hospital/Allama Iqbal Medical College, Lahore

Fahad Iqbal, FCPS

Role: STUDY_DIRECTOR

Sir Ganga Ram Hospital Lahore

Locations

Jinnah Hospital/Allama Iqbal Medical College

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

DRSAIMA-JHLAHORE

Identifier Type: -

Identifier Source: org_study_id