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

Muhammad Aamir Latif

Status: Completed

Conditions: Tinea Capitis

Treatments: Drug: Terbinafine; Drug: Itraconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT07068256

DRSAIMA-JHLAHORE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 1 to 13 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Terbinafine group

Experimental group

Description:

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.

Treatment:

Drug: Terbinafine

Itraconazole group

Experimental group

Description:

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.

Treatment:

Drug: Itraconazole