Clinical, Dermoscopic, and Mycological Evaluations of Resistant Dermatophytosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-80
SponsorSohag University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Exclusion criteria

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Direct microscopic KOH examination

    Diagnostic test

    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

  • 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

  • Antifungal susceptibility testing:

    Diagnostic test

    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

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
October 2026- March 2027
2

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

Time frame
January 2027- April 2027
3

Determine the in vitro susceptibility profile of dermatophyte isolates.

Time frame
April 2027 to June 2027
4

Molecular identification of different species of dermatophytes using PCR.

Time frame
June 2027 to August 2027

Secondary outcomes

Other outcomes

Sponsors and contacts

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