Fungal Skin InfectionNCT07796854
Clinical, Dermoscopic, and Mycological Evaluations of Resistant Dermatophytosis
An observational study of Fungal Skin Infection and Tinea Corporis, run by Sohag University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Fungal Skin Infection, Tinea Corporis
- What is being tested?
- Direct microscopic KOH examination, Culture: and Antifungal susceptibility testing:
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 20 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marwa Ragab Yassen, Demonstrator contact
Egypt1 site
Sohag university, Faculty of medicine
Sohag
Noha Shafik, 01067261504, nohasaber@med.sohag.edu.eg
marwa Ragheb
About this study
Official title: Clinical, Dermoscopic, and Mycological Evaluations of Resistant Dermatophytosis of Non-glabrous Skin: A Cross-sectional Study
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.
- Conditions
- Fungal Skin Infection, Tinea Corporis
- Being tested
- Direct microscopic KOH examination, Culture:, Antifungal susceptibility testing:, Conventional PCR:
- Keywords
- Dermatophytosis, resistance, PCR, antifungal
- Medical subject headings
- Dermatomycoses, Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct microscopic KOH examinationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop | Not described Receives: Diagnostic Test: Direct microscopic KOH examination; Diagnostic Test: Culture:; Diagnostic Test: Antifungal susceptibility testing:; Diagnostic Test: Conventional PCR: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical and dermoscopic features of resistant dermatophytosis of non-glabrous skin.
Measured: October 2026- March 2027
Assess of the mycological features of resistant dermatophytosis of non-glabrous skin.
Measured: January 2027- April 2027
Determine the in vitro susceptibility profile of dermatophyte isolates.
Measured: April 2027 to June 2027
Molecular identification of different species of dermatophytes using PCR.
Measured: June 2027 to August 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal Skin InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ragb Hassan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796854
- Sponsor's protocol ID
- Soh-Med-26-8-9MS
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Dermoscopic, and Mycological Evaluations of Resistant Dermatophytosis of Non-glabrous Skin: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07796854
- Acronym / sponsor ID
- Soh-Med-26-8-9MS
- Conditions
- Fungal Skin Infection, Tinea Corporis
- Keywords
- Dermatophytosis, resistance, PCR, antifungal
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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: |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct microscopic KOH examinationClinicians 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 test | Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop |
| Culture: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 test | Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop |
| Antifungal 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 test | Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop |
| Conventional 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. | Diagnostic test | Clinically diagnosed resistant dermatophytosis (e.g., tinea corporis, cruris,…), resistant dermatop |
Primary outcome
Evaluate the clinical and dermoscopic features of resistant dermatophytosis of non-glabrous skin.
Time frame: October 2026- March 2027
Assess of the mycological features of resistant dermatophytosis of non-glabrous skin.
Time frame: January 2027- April 2027
Determine the in vitro susceptibility profile of dermatophyte isolates.
Time frame: April 2027 to June 2027
Molecular identification of different species of dermatophytes using PCR.
Time frame: June 2027 to August 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marwa Ragab Yassen, Demonstrator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal Skin Infection and Tinea Corporis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha Shafik, Assistant professor (01067261504, nohasaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical and dermoscopic features of resistant dermatophytosis of non-glabrous skin. (time frame: October 2026- March 2027). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.