NCT07184203

Brief Summary

A study to compare the efficacy of daily therapy versus pulse therapy of oral itraconazole in the treatment of tinea capitis in children based on clinical, mycological and dermoscopic evaluation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 19, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

September 14, 2025

Last Update Submit

September 14, 2025

Conditions

Tinea Capitis

Outcome Measures

Primary Outcomes (1)

  • improvement of tinea capitis

    cure of tinea capitis

    3 months

Study Arms (2)

Group A will receive itraconazole continuous daily regimen

ACTIVE COMPARATOR
Drug: Itraconazole (ITZ)

Group B will receive itraconazole pulse regimen

ACTIVE COMPARATOR
Drug: Itraconazole (ITZ)

Interventions

Itraconazole (ITZ)DRUG

therapy for tinea capitis orally

Group A will receive itraconazole continuous daily regimenGroup B will receive itraconazole pulse regimen

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Tinea capitis patients with ages ranging from 5 to 18 year

You may not qualify if:

  • Patients with contraindications to itraconazole
  • Patients with associated scalp disease.
  • Patients weighing less than 20 Kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Tinea Capitis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousScalp DermatosesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Central Study Contacts

Marina K Aioub

CONTACT

00201223805043marinaaioub10@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general practitioner

Study Record Dates

First Submitted

September 14, 2025

First Posted

September 19, 2025

Study Start

March 9, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)