ClinicalTrials.gg
Not yet recruitingNCT07796854Updated Sep 1, 2026

Clinical, Dermoscopic, and Mycological Evaluations of Resistant Dermatophytosis

An observational study in Fungal Skin Infection and Tinea Corporis, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Year to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
1 Year to 80 Years
Sex
All
01

Study 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

Read the detailed description

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.

02

Conditions studied

  • Fungal Skin Infection
  • Tinea Corporis

Browse trials for

Keywords

  • Dermatophytosis
  • resistance
  • PCR
  • antifungal
03

In context

Tinea

39 studies on the registry are indexed under Tinea; 8 are open to participants now.

Browse Tinea studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Eligibility criteria

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

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

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

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

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

Interventions

  • Diagnostic testDirect microscopic KOH examination

    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

  • Diagnostic testCulture:

    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

  • Diagnostic testAntifungal susceptibility testing:

    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

  • Diagnostic testConventional PCR:

    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.

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Sep 1, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Nov 20, 2026
CompletionEst.
Aug 20, 2027
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07796854
Lead sponsor
Sohag University
Responsible party
Marwa Ragb Hassan (Demonstrator of dematology and venerology, Sohag University) — Principal investigator
First posted
Sep 1, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Nov 20, 2026 (estimated)
Completion
Aug 20, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

Noha Shafik, Assistant professor
Contact
nohasaber@med.sohag.edu.eg
01067261504
Marwa Ragab Yassen, Demonstrator
Contact

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion