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NCT Number: NCT07796854

Clinical, Dermoscopic, and Mycological Evaluations of Resistant Dermatophytosis

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

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Key information

Age range

1 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag university, Faculty of medicine

Sohag, Egypt

Location contact

Mohammed Abu El-Hamd Ali, Professor

SUB_INVESTIGATOR

Noha Shafik

CONTACT

[email protected]

01067261504

Rasha Ismail Mohamed Ali, Professor

SUB_INVESTIGATOR

marwa Ragheb

CONTACT

About this study

According to surveys conducted by the World Health Organisation, it has been found that approximately 25% of the global population is impacted by dermatophytes. Males are more likely to have dermatophytosis infections caused by the physiological structure of males who are more active outdoors and demand physical activity to provide conditions conducive to the growth of dermatophytes . On the other hand, female is less likely to be infected with dermatophytes, which is associated with their lifestyle, including a lot of housework, indoor activities, and hormonal factors. Dermatophytosis is a multifactorial disease influenced by the interaction of host, environmental, and behavioral factors. Major risk factors include hot and humid climates, excessive sweating, poor personal hygiene, the use of occlusive clothing or footwear, overcrowding, and low socioeconomic status . In addition, close contact with infected individuals, contaminated fomites, or infected animals facilitates disease transmission. Certain medical conditions, including diabetes mellitus, obesity, peripheral vascular disease, and immunosuppression, increase susceptibility to infection by impairing host defense mechanisms. Dermatophytosis spreads easily among persons and animals, and by shared objects or surfaces such as clothing and locker room floors. Its more predominant in the tropical and subtropical countries; especially in the developing countries where hot climate and humid weather is favorable to the acquisition and maintenance of the disease. The causative organisms of these infections can be classified based on their ecological niche: anthropophilic species, which primarily infect humans; zoophilic species, which originate from animals; and geophilic species, which are found in soil. The most common causative organisms affecting humans belong to the genera ;Trichophyton, Microsporum, and Epidermophyton . Trichophyton rubrum is the most common causative agent in high income countries, and Trichophyton mentagrophytes species complex, Microsporum canis, and Epidermophyton floccosum are most prevalent globally. Trichophyton schoenleinii, Trichophyton soudanese, and Trichophyton concentricum are generally limited to parts of Europe, Asia, and Africa . Classically, dermatophytosis affecting the skin causes a characteristic red, scaly, itchy, ring-shaped lesion with central clearing.

Historically, clinicians and laboratory scientists have viewed dermatophytosis as a mild condition meriting less attention compared with invasive, life-threatening infections such as candidemia and invasive pulmonary aspergillosis . However, the epidemiology of dermatophytosis has changed dramatically in the last decade because of the emergence of dermatophyte strains causing infections that are increasingly severe and difficult-to-treat The reasons for the emergence of resistant strains have not been fully researched, but in India, potent steroid creams combined with antifungal agents and antimi-crobial agents are freely available and have been sold in large quantities over the counter. These preparations actually being cheaper than pure antifungal agents mean they are the often first choice for consumers . The misuse of antifungal agents, over-the-counter available antimycotics, patient non-compliance, treatment combinations of antifungals with topical steroids, as well as changes relative to travel and migration, all are contributing factors to a global increase in antifungal resistance . In the last few years, awareness has been raised internationally about the growing threat of fungal resistance to common antifungal agents.

Globally, Trichophyton rubrum is the most frequently identified cause of dermatophytosis. However, Trichophyton indotineae (T. indotineae), a newly identified species within the Trichophyton mentagrophytes complex, has recently emerged as the predominant pathogen in India and other parts of Asia. T. indotineae exhibits an anthropophilic instead of a zoophilic transmission pattern and has developed a high level of terbinafine resistance . Due to globalization, this new emerging pathogen has been isolated in many countries outside Asia, causing an epidemic of severe, recalcitrant dermatophytosis. Patients with these infections can present with double-edged or multiedged tinea concentric scaly rings. Large lesions with multiple, closely juxtaposed, centrifugally spreading lesions with eczematous centers have also been described , and have frequent relapses and treatment failures due to antifungal resistance, including resistance to terbinafine and the azoles itraconazole and voricon. Diagnostic testing for suspected dermatophyte infections is important to help minimize overuse and incorrect use of antifungal drugs, which may contribute to resistance development . Unfortunately, diagnostic testing may be disincentivized due to low reimbursement rates, long turnaround times, and Clinical Laboratory Improvement Amendments (CLIA)-related restrictions on in-office microscopy . These gaps might be addressed through increased adoption of polymerase chain reaction (PCR)-based testing to identify dermatophyte species and development of rapid, accurate, and affordable point-of-care tests for dermatophyte identification.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • Patients receiving immunosuppressive drugs (systemic corticosteroids or other immunomodulatory drugs).

Treatment and study plan

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa Ragab Yassen, Demonstrator

CONTACT

Noha Shafik, Assistant professor

CONTACT

[email protected]

01067261504

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Clinical, Dermoscopic, and Mycological Evaluations of Resistant Dermatophytosis of Non-glabrous Skin: A Cross-sectional Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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