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Completed

NCT Number: NCT07068256

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

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.

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Key information

Conditions

Tinea Capitis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Scalp Dermatoses Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah Hospital/Allama Iqbal Medical College

Lahore, Punjab Province, 54700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terbinafine

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

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.

Primary outcomes

  1. Fungus eradication

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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