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

NCT07068256 | Completed

• 1 other identifier: DRSAIMA-JHLAHORE
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinea Capitis

Outcome Measures

Primary Outcomes (1)

• Fungus eradication

  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.

  9 weeks

Study Arms (2)

Terbinafine group

EXPERIMENTAL

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.

Drug: Terbinafine

Itraconazole group

EXPERIMENTAL

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.

Drug: Itraconazole

Interventions

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.

Terbinafine group

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.

Itraconazole group

Eligibility Criteria

• Age: 1 Year - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Jinnah Hospital/Allama Iqbal Medical College

Lahore, Punjab Province, 54700, Pakistan

Location

MeSH Terms

Conditions

Tinea Capitis

Interventions

Terbinafine; Itraconazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Saima Aslam

  Jinnah Hospital/Allama Iqbal Medical College, Lahore

  PRINCIPAL INVESTIGATOR

• Fahad Iqbal, FCPS

  Sir Ganga Ram Hospital Lahore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: April 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)