NCT07796854

Brief Summary

Dermatophytosis is a common superficial infection of the skin, hair, or nails caused by dermatophyte, it is colloquially known as ringworm or tinea infection and affects an estimated one in five people in their lifetime

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 Oct 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

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Aug 2027

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 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 1, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 27, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

DermatophytosisresistancePCRantifungal

Outcome Measures

Primary Outcomes (4)

  • Evaluate the clinical and dermoscopic features of resistant dermatophytosis of non-glabrous skin.

    October 2026- March 2027

  • Assess of the mycological features of resistant dermatophytosis of non-glabrous skin.

    January 2027- April 2027

  • Determine the in vitro susceptibility profile of dermatophyte isolates.

    April 2027 to June 2027

  • Molecular identification of different species of dermatophytes using PCR.

    June 2027 to August 2027

Study Arms (1)

Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop

Diagnostic Test: Direct microscopic KOH examinationDiagnostic Test: Culture:Diagnostic Test: Antifungal susceptibility testing:Diagnostic Test: Conventional PCR:

Interventions

Clinicians typically will use a scalpel or curette to scrape the lesion's edge, particularly the most recent lesion where fungal elements are most likely to be found . Specimens will be collected after proper skin cleansing with alcohol 70 % a and sealed in sterile dry Petri dishes (Gold and Lockhart, 2025). Samples will be labeled with the patient's name, age, sex, date of collection, and site of infection and subsequently brought to the laboratory for mycological examination . The samples collected will be screened for the presence of fungal elements using a 10% KOH with 40% Dimethyle sulphoxide (DMSO) mount mixed in equal proportion

Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop
Culture:DIAGNOSTIC_TEST

After a direct microscopic examination, skin scraping specimens will be inoculated in a Petri dish: containing sabrouds Dextrose Agar added to it (chloramphenicol ) acts as a broad spectrum antibiotic, which inhibits a wide range of gram-positive and gram-negative bacteria) and cycloheximide (to inhibit saprophytic fungi) and other Petri dish containing Dermasel agar base, supplemented with chloramphenicol and cycloheximide. Cultures will be incubated aerobically at room temperature (25°C) for up to 4 weeks. Positive cultures will be examined both macroscopically (color of the surface and reverse, topography, and texture) and microscopically (after staining of growth colony with lactophenol cotton blue stain or methylene blue stain) to determine two types of conidia for species identification. In the absence of any growth after 4 weeks, the culture will be considered negative

Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop

Agar Based Disc Diffusion (ABDD) antifungal susceptibility testing will be performed using eight antifungal agents: Clotrimazole, Miconazole, Fluconazole, Ketoconazole, Terbinafine, Voriconazole, Itraconazole and Griseofulvin on Mueller-Hinton medium. When growth occurs, the size of the zones of inhibition around the disks will be measured and recorded. Criteria of susceptibility and resistance of antifungal agents will be measured according to clinical and laboratory standards institutes (CLSI

Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop
Conventional PCR:DIAGNOSTIC_TEST

1. Extraction of fungal nucleic acid: will be done using commercial kits. 2. Amplification and detection of different species using species- specific primers by conventional PCR.

Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

It's a cross sectional study will be conducted on patients attending the outpatient clinic of Dermatology, Venereology, and Andrology department in Sohag University Hospital over a period of 12 months between August, 2026 to July, 2027. Setting : Outpatient clinic of Dermatology, Venereology, and Andrology department in Sohag University Hospital.

You may qualify if:

  • Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatophytosis (no cure despite adequate antifungals), recurrent (reoccurrence \<6 weeks post treatment) or disease duration \>6-12 months (Gharib et al., 2024) . 2. Age \>18 years, both sex.

You may not qualify if:

  • Pregnant or lactating women will be routinely excluded due to potential risks of antifungal medication.
  • Patients with recent systemic antifungal use (often within 1 month) or topical antifungals (within 2 weeks).
  • Chronic systemic diseases (e.g., diabetes mellitus, hepatic or renal impairment).
  • Patients receiving immunosuppressive drugs (systemic corticosteroids or other immunomodulatory drugs).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university, Faculty of medicine

Sohag, Egypt

Location

Related Links

MeSH Terms

Conditions

DermatomycosesTinea

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Noha Shafik, Assistant professor

CONTACT

Marwa Ragab Yassen, Demonstrator

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of dematology and venerology

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

August 20, 2027

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations