NCT07802600

Brief Summary

Tinea capitis is a common dermatophyte infection of the scalp in children aged 0-9 years .The prevalence of tinea capitis in Egypt is 0.4% and higher in public than private schools, Boys were more affected than girls according to children by 5:1 ratio , It is more prevalent in those who live in urban areas, large families, low socioeconomic level, crowded living conditions and immunocompromised people . Tinea capitis is caused by dermatophyte fungi Trichophyton and Microsporum genera. These fungi are classified as: anthropophilic, zoophilic, and geophilic according to the route of infection. These fungi invade the hair shaft in two routes: ectothrix and endothrix . T.tonsurans and T.violaceum are reported to be the most common cause of tinea capitis

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Aug 2027

First Submitted

Initial submission to the registry

August 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2027

Last Updated

September 3, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

August 28, 2026

Last Update Submit

September 1, 2026

Conditions

Keywords

Tinea capitisantifungal resistancedermatophyteKOH

Outcome Measures

Primary Outcomes (3)

  • Percentage of participants presenting with specific clinical patterns of tinea capitis

    Clinical evaluation will be performed to identify and classify the presentation of tinea capitis lesions (e.g., scaly patches, black dots, kerion, favus).

    At the time of initial clinical evaluation

  • Percentage of participants exhibiting specific dermoscopic features of tinea capitis

    Dermoscopic examination using a handheld dermatoscope to identify characteristic signs including comma hairs, corkscrew hairs, broken hairs, and scaling.

    At the time of initial dermoscopic evaluation

  • Prevalence of isolated fungal species among pediatric tinea capitis cases

    Mycological evaluation including direct microscopic KOH preparation and fungal culture on agar media to isolate and identify the causative fungal pathogens.

    At the time of initial sample collection and culture identification

Study Arms (1)

patients with tinea capitis both male and female in childhood period

Diagnostic Test: Dermoscopic examination: the findings are divided into pathognomic and non-specific signsDiagnostic Test: Direct Microscopy (KOH) examinationDiagnostic Test: Fungal culture:Diagnostic Test: Antifungal sensitivity:

Interventions

Fungal culture:DIAGNOSTIC_TEST

Specimen will be cultured on sabouraud's dextrose agar (SDA) at 25 -30 c for 2 to 4 weeks and another specimen will be cultured on a Dermasel agar base (Oxoid, UK), both supplemented with chloramphenicol and cycloheximide , staining the fungal colonies by Lactophenol cotton blue to help the examination of colonial morphology and microscopic examination of the macro-conidia allow the identification of the dermatophyte species and suitable treatment

patients with tinea capitis both male and female in childhood period

Antifungal susceptibility testing will be performed to determine the specific sensitivity profiles of the fungal isolates. Antifungal susceptibility testing will be performed using seven antifungal agents: Terbinafine, Itraconazole, Griseofulvin, Fluconazole, Ketoconazole, Vorioconole and Miconazole. Dermatophytes colonies will be probed from Dermasel agar cultures.

patients with tinea capitis both male and female in childhood period

1. Pathognomic signs: comma hairs, corkscrew hairs, Morse code like hairs and zig-zag hairs. 2. Non-specific signs: black dots, broken hairs, perifollicular scaling and inter follicular erythema

patients with tinea capitis both male and female in childhood period

1. Suspected lesions will be swabbed with 70% ethyl alcohol then scalp scraping using the blunt edge of a sterile surgical blade 2. Skin scales and crusts will be collected from the erythematous, peripheral, actively expanding edges of the lesions onto clean glass slides by scraping the inflamed lesions the scales will contain infected stumps of hair 3. Hair will be removed with the root intact (hair cutting will be avoided) 4. Specimen will be prepared by mounting the sample in (10-30%) of potassium hydroxide with 40% Dimethyle sulphoxide (DMSO) drops on the petri slide to soften the tissue, allowing a thin layer of cells to form.

patients with tinea capitis both male and female in childhood period

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted at the Dermatology Outpatient Clinic in Sohag University Hospitals. Study population: The study population will be all patients with tinea capitis both male and female in childhood period, Aged 1-18 years old

You may qualify if:

  • \- Both male and female in childhood period (1-18 years) with tinea capitis

You may not qualify if:

  • Topical or systemic antifungal medications one month prior to enrollment in the study
  • Presence of systemic disease, such as hepatic,renal, cardiac, autoimmune diseases, or malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine , Sohag university

Sohag, Egypt

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

1. Suspected lesions will be swabbed with 70% ethyl alcohol then scalp scraping using the blunt edge of a sterile surgical blade 2. Skin scales and crusts will be collected from the erythematous, peripheral, actively expanding edges of the lesions onto clean glass slides by scraping the inflamed lesions the scales will contain infected stumps of hair 3. Hair will be removed with the root intact (hair cutting will be avoided) 4. Specimen will be prepared by mounting the sample in (10-30%) of potassium hydroxide with 40% Dimethyle sulphoxide (DMSO) drops on the petri slide to soften the tissue, allowing a thin layer of cells to form.

MeSH Terms

Conditions

Tinea Capitis

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Mohammed Abu El Hamd Ali

    Faculty of Medicine , Sohag university

    STUDY CHAIR
  • Doaa Gaber Abdelbaset

    Faculty of Medicine , Sohag university

    STUDY CHAIR

Central Study Contacts

Noha Shafik, Assistant professor

CONTACT

Walaa Hemdan Abu Alhassan, Demonstrator

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator ,demonstrator of dermatology and andrology

Study Record Dates

First Submitted

August 28, 2026

First Posted

September 3, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

August 20, 2027

Last Updated

September 3, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations