Clinical and Laboratory Evaluation of Antifungal Resistance in Tinea Capitis

May 1, 2024 updated by: Reem Atef Ibrahim, Assiut University

AIM OF WORK :

  1. Detect the most common fungal strains that cause tinea capitis
  2. Detect Different effectiveness of terbinafine in different cases
  3. Detect the resistant strains.
  4. Detect the mycological and the clinical cure rates upon using systemic terbinafine in treatment of tinea capitis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction:

  • Tinea capitis is a superficial fungal infection of the skin of the scalp, with a propensity for attacking hair shafts and follicles . The disease is considered to be a form of superficial mycosis or dermatophytosis
  • It may affect all or part of the child's scalp.
  • Mold-like fungi called dermatophytes cause tinea capitis ,It is caused primarily by Dermatophyte species Microsporm and trichopyton,, In Egypt, dermatophytes called Microsporum canis and Microsporum audouinii are the most common causes of the infection. Fungi thrive in warm, moist environments. It commonly grows in tropical places.
  • Tinea capitis can be divided into inflammatory and non-inflammatory types, the non-inflammatory type usuallywill not be complicated by scaring alopecia , the inflammatory type may result in Kerion ,a painful nodule with pus and scaring alopecia, The clinical manifestations of tinea capitis are classified as endothrix, ectothrix, or favus. In the endothrix form, hyphae grow down the follicle and penetrate the hair shaft, then grow completely within the hair shaft. This form is caused predominantly by T. tonsurans and T. violaceum In the ectothrix form, the hyphae invade the hair shaft at mid follicle. Afterwards, hyphae grow out of the follicle covering the hair surface. This form is caused by M. canis, M. audouinii, Microsporum ferrugineum, and Trichophyton verrucosum. The hyphae grow parallel to the hair shaft in favus form then degenerate, leaving long tunnels within the hair shaft. Favus form is caused by Trichophyton schoenleinii and is characterized by yellow crust around the hair shafts and can result in permanent scarring alopecia.
  • ♦ Tinea capitis also spreads very easily. The patients can catch the infection from contact with infected people, animals and soil. They can also get it by using objects and touching surfaces that harbor the fungus. Tinea capitis can live for a long time on infected objects and surfaces. It is very contagious and can spread quickly among children
  • The diagnosis is suspected primarily clinically based on the appearance of the scalp lesion. A Wood's lamp test performed to confirm the presence of a fungal scalp infection , Dermoscopy is a useful and non invasive diagnostic tool which aids in the diagnosis of tinea capitis ,the diagnosis can be confirmed by microscopic examination of KOH,
  • Fungal culture is the gold standard to diagnose dermatophytosis,
  • fungal culture can help to differentiate fungal species
  • The treatment of tinea capitis requires systemic antifungal therapy because topical antifungal agents cannot penetrate the hair shaft sufficiently to eradicate infection. Griseofulvin, the former gold standard agent, has been associated with treatment failure; a retrospective review of patients' medical records revealed a failure rate of 39.3% , in octobr 2007 The FDA has approved terbinafine oral granules (Lamisil), which can be sprinkled on food, for tinia capitis in children four years and older , fluconazole and Itraconazole also used in treatment of Tinea capitis although they are not FDA approved
  • In the past few years , Numerous cases of tinea capitis that was initially resistant to systemic antifungal or recurred rapidly after a brief interval improvement recently have been seen
  • In general, clinical resistance is considered to be the persistence or progression of an infection despite appropriate antimicrobial therapy , This resistance can be attributed to a combination of factors related to the host, the antifungal agent, or the pathogen .

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients from both sexes aged > 4 years old.
  • patients have tinea capitis (scaly type)

Exclusion Criteria:

  • Patients have other types of tinea capitis infection.
  • Patients with heart valve diseases , Hearing loss , liver or kidney diseases.
  • Pregnant or lactating females.
  • Personal or family history of malignancy.
  • Immunocompramised patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Terbinafine

Patients will be treated by systemic terbinafine alone for 6 weeks

• Dosage: 25 kg for 125 mg 25-35 kg for 187.5 mg 35 for 250 mg
Drug: Terbinafine
FDA approved

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
-Detect the most common Fungal strains that cause tinea capitis
Time Frame: Baseline
  • Detect the most common Fungal strains that cause tinea capitis by doing :
  • Fungal culture after gentle scraping of surface of affected area.
Baseline
Resistant strain in tinea capitis
Time Frame: Baseline
- Detect the resistant strain by using culture of scrapped sample.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Alaa Moubasher, Professor, supervisor
  • Study Director: Radwa Bakr, Professor, supervisor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 18, 2023

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fungal resistance

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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