DermatophytosisNCT07898475
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
An observational study of Dermatophytosis and Tinea Corporis, run by Dr. Amara Safdar at 1 site in Pakistan.
Trial summary
Dermatophyte infections of the skin, hair and nails are common in Pakistan, and treatment failure with standard antifungal drugs is increasingly reported. Local laboratory data on how dermatophytes respond to terbinafine and itraconazole are limited. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dermatophytosis, Tinea Corporis, Tinea Cruris
- What is being tested?
- In vitro antifungal susceptibility testing
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Oct 2026to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients attending the dermatology outpatient department of Allied Hospital, Faisalabad Medical University, Faisalabad, Pakistan, with clinically suspected, KOH-confirmed dermatophytosis.
Who may be able to join
- Clinically suspected dermatophytosis confirmed by KOH microscopy
- Male and female patients of all age groups
- Informed consent from the patient, or from a parent/guardian with child assent for those under 18 years
Who cannot join
- Current systemic antifungal therapy, or topical or systemic antifungal use within the previous 2 weeks
- Immunocompromised patients
- Pregnant or lactating women
- Unwilling to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Allied Hospital, Faisalabad Medical University
Faisalabad, Punjab Province, 38000
Kalsoom Jawaid, MBBS, FCPS, CMT, +923214470345, dr.klsmjwd@gmail.com
Kalsoom Jawaid, MBBS, FCPS, CMT
About this study
Dermatophyte infections of the skin, hair and nails are common in Pakistan, and treatment failure with standard antifungal drugs is increasingly reported. Local laboratory data on how dermatophytes respond to terbinafine and itraconazole are limited. This study will collect skin scrapings, hair or nail samples from consecutive dermatology outpatients with KOH-confirmed dermatophytosis, grow the fungi in culture, and test each isolate against terbinafine and itraconazole using the standard CLSI M38 broth microdilution method. The study will report the proportion of Trichophyton isolates with an elevated terbinafine minimum inhibitory concentration (MIC), the MIC distributions of both drugs, and the species involved, and will explore whether elevated terbinafine MICs are associated with clinical features such as disease duration, previous antifungal use and topical corticosteroid use. Participation does not change treatment; the study only tests samples in the laboratory.
Read the detailed description
Design and setting: Descriptive cross-sectional study with non-probability consecutive sampling, conducted at the Department of Dermatology, Allied Hospital, Faisalabad Medical University, Faisalabad, Pakistan. Mycological culture and antifungal susceptibility testing are performed by the Microbiology Laboratory, University of Agriculture, Faisalabad.
Data collection: Demographic and clinical data are recorded on a structured proforma, including clinical type, disease duration (months), affected sites, previous antifungal use (route and date of last use) and topical corticosteroid use. Specimens are labelled with coded study IDs; patient identifiers are held separately by the principal investigator. One isolate per patient is tested, from the clinically most extensive site if more than one specimen is positive.
Laboratory methods: Specimens are cultured on Sabouraud dextrose agar with chloramphenicol and cycloheximide at 25-28 C for up to four weeks. Identification is by colony morphology and lactophenol cotton blue mount; isolates of the Trichophyton mentagrophytes/interdigitale complex are reported at complex level, as molecular identification is not performed. Susceptibility to terbinafine and itraconazole is tested by CLSI M38 broth microdilution in RPMI 1640 with MOPS and 0.2% glucose (final drug concentrations 0.03-16 ug/mL; final inoculum approximately 0.4-5 x 10^4 CFU/mL), incubated at 35 C and read at day 4, extended to day 7 if growth is insufficient. The MIC is the lowest concentration producing at least 80% growth inhibition compared with the growth control, read independently by two readers blinded to clinical details. Growth and sterility controls are included in each run.
Interpretation: A Trichophyton isolate with a terbinafine MIC of 0.5 ug/mL or higher is classified as having a study-defined elevated MIC. This is not a validated clinical breakpoint and is not interpreted as clinical resistance. Itraconazole MICs and MICs of other genera are reported descriptively.
Sample size: 71 evaluable Trichophyton isolates (single-proportion formula; expected proportion 0.757 from a Pakistani study; 95% confidence; absolute precision 0.10). Recruitment continues consecutively until 71 Trichophyton isolates have been successfully tested.
Analysis: The primary proportion is reported with a Wilson 95% confidence interval. MIC range, MIC50, MIC90 and distributions are reported by drug and species. Associations between elevated terbinafine MIC and clinical variables are explored using chi-square or Fisher's exact test. A sensitivity analysis excludes patients with systemic antifungal exposure in the 4 weeks before specimen collection.
- Conditions
- Dermatophytosis, Tinea Corporis, Tinea Cruris, Tinea Pedis, Onychomycosis
- Being tested
- In vitro antifungal susceptibility testing
- Keywords
- terbinafine, itraconazole, antifungal susceptibility testing, minimum inhibitory concentration, broth microdilution, Trichophyton, Trichophyton indotineae, CLSI M38, Pakistan
- Medical subject headings
- Tinea, Tinea Cruris, Tinea Pedis, Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro antifungal susceptibility testingOther
Broth microdilution (CLSI M38) testing of each fungal isolate against terbinafine and itraconazole. Laboratory test on specimens only; patient treatment is not altered.
| Study group | Role | What they receive |
|---|---|---|
| Patients with KOH-confirmed dermatophytosis | Consecutive dermatology outpatients of any age with clinically suspected, KOH-confirmed dermatophytosis. No intervention is given; clinical specimens are cultured and isolates undergo in vitro antifungal susceptibility testing. Receives: Other: In vitro antifungal susceptibility testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Trichophyton isolates with elevated terbinafine MIC
Percentage of evaluable Trichophyton isolates with a terbinafine minimum inhibitory concentration (MIC) of 0.5 ug/mL or higher (study-defined elevated MIC), determined by CLSI M38 broth microdilution with an 80% inhibition endpoint, reported with a Wilson 95% confidence interval.
Measured: Up to 7 weeks after specimen collection
Secondary outcomes (4)
Terbinafine MIC distribution, range, MIC50 and MIC90
Terbinafine MIC values (ug/mL) of all dermatophyte isolates, reported by species.
Measured: Up to 7 weeks after specimen collection
Itraconazole MIC distribution, range, MIC50 and MIC90
Itraconazole MIC values (ug/mL) of all dermatophyte isolates, reported descriptively by species.
Measured: Up to 7 weeks after specimen collection
Species distribution of dermatophyte isolates
Number and percentage of isolates of each dermatophyte species or complex, identified by culture morphology and lactophenol cotton blue mount.
Measured: Up to 4 weeks after specimen collection
Association of elevated terbinafine MIC with clinical variables
Proportion of Trichophyton isolates with elevated terbinafine MIC compared across clinical type, disease duration (less than 6 vs 6 months or longer), previous antifungal use (none, topical only, systemic) and topical corticosteroid use, using chi-square or Fisher's exact test (exploratory).
Measured: Up to 7 weeks after specimen collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start2 Oct 2026
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatophytosisStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Amara Safdar
- Sponsor type
- University, hospital or other
- Collaborators
- Faisalabad Medical University, University of Agriculture Faisalabad, Allied Hospital Faisalabad
- Responsible party
- Sponsor-investigator, Dr. Amara Safdar, Allied Hospital Faisalabad
- Investigators
- Kalsoom Jawaid, MBBS, FCPS, CMT, Principal investigator, Faisalabad Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898475
- Sponsor's protocol ID
- Susceptibility of Dermatophyte
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared. De-identified aggregate results will be reported in publications; individual data may be made available on reasonable request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
- ClinicalTrials.gov ID
- NCT07898475
- Acronym / sponsor ID
- Susceptibility of Dermatophyte
- Conditions
- Dermatophytosis, Tinea Corporis, Tinea Cruris, Tinea Pedis, Onychomycosis
- Keywords
- terbinafine, itraconazole, antifungal susceptibility testing, minimum inhibitory concentration, broth microdilution, Trichophyton, Trichophyton indotineae, CLSI M38
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr. Amara SafdarUniversity, hospital or other
- Collaborators
- Faisalabad Medical University, University of Agriculture Faisalabad, Allied Hospital Faisalabad
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Oct 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.
Dermatophyte infections of the skin, hair and nails are common in Pakistan, and treatment failure with standard antifungal drugs is increasingly reported. Local laboratory data on how dermatophytes respond to terbinafine and itraconazole are limited. This study will collect skin scrapings, hair or nail samples from consecutive dermatology outpatients with KOH-confirmed dermatophytosis, grow the fungi in culture, and test each isolate against terbinafine and itraconazole using the standard CLSI M38 broth microdilution method. The study will report the proportion of Trichophyton isolates with an elevated terbinafine minimum inhibitory concentration (MIC), the MIC distributions of both drugs, and the species involved, and will explore whether elevated terbinafine MICs are associated with clinical features such as disease duration, previous antifungal use and topical corticosteroid use. Participation does not change treatment; the study only tests samples in the laboratory.
Detailed description
Design and setting: Descriptive cross-sectional study with non-probability consecutive sampling, conducted at the Department of Dermatology, Allied Hospital, Faisalabad Medical University, Faisalabad, Pakistan. Mycological culture and antifungal susceptibility testing are performed by the Microbiology Laboratory, University of Agriculture, Faisalabad.
Data collection: Demographic and clinical data are recorded on a structured proforma, including clinical type, disease duration (months), affected sites, previous antifungal use (route and date of last use) and topical corticosteroid use. Specimens are labelled with coded study IDs; patient identifiers are held separately by the principal investigator. One isolate per patient is tested, from the clinically most extensive site if more than one specimen is positive.
Laboratory methods: Specimens are cultured on Sabouraud dextrose agar with chloramphenicol and cycloheximide at 25-28 C for up to four weeks. Identification is by colony morphology and lactophenol cotton blue mount; isolates of the Trichophyton mentagrophytes/interdigitale complex are reported at complex level, as molecular identification is not performed. Susceptibility to terbinafine and itraconazole is tested by CLSI M38 broth microdilution in RPMI 1640 with MOPS and 0.2% glucose (final drug concentrations 0.03-16 ug/mL; final inoculum approximately 0.4-5 x 10^4 CFU/mL), incubated at 35 C and read at day 4, extended to day 7 if growth is insufficient. The MIC is the lowest concentration producing at least 80% growth inhibition compared with the growth control, read independently by two readers blinded to clinical details. Growth and sterility controls are included in each run.
Interpretation: A Trichophyton isolate with a terbinafine MIC of 0.5 ug/mL or higher is classified as having a study-defined elevated MIC. This is not a validated clinical breakpoint and is not interpreted as clinical resistance. Itraconazole MICs and MICs of other genera are reported descriptively.
Sample size: 71 evaluable Trichophyton isolates (single-proportion formula; expected proportion 0.757 from a Pakistani study; 95% confidence; absolute precision 0.10). Recruitment continues consecutively until 71 Trichophyton isolates have been successfully tested.
Analysis: The primary proportion is reported with a Wilson 95% confidence interval. MIC range, MIC50, MIC90 and distributions are reported by drug and species. Associations between elevated terbinafine MIC and clinical variables are explored using chi-square or Fisher's exact test. A sensitivity analysis excludes patients with systemic antifungal exposure in the 4 weeks before specimen collection.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with KOH-confirmed dermatophytosis | – | Other: In vitro antifungal susceptibility testingConsecutive dermatology outpatients of any age with clinically suspected, KOH-confirmed dermatophytosis. No intervention is given; clinical specimens are cultured and isolates undergo in vitro antifungal susceptibility testing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients attending the dermatology outpatient department of Allied Hospital, Faisalabad Medical University, Faisalabad, Pakistan, with clinically suspected, KOH-confirmed dermatophytosis.
Key inclusion criteria (3 listed)
- Clinically suspected dermatophytosis confirmed by KOH microscopy
- Male and female patients of all age groups
- Informed consent from the patient, or from a parent/guardian with child assent for those under 18 years
Key exclusion criteria (4 listed)
- Current systemic antifungal therapy, or topical or systemic antifungal use within the previous 2 weeks
- Immunocompromised patients
- Pregnant or lactating women
- Unwilling to participate
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 |
|---|---|---|
| In vitro antifungal susceptibility testingBroth microdilution (CLSI M38) testing of each fungal isolate against terbinafine and itraconazole. Laboratory test on specimens only; patient treatment is not altered. | Other | Patients with KOH-confirmed dermatophytosis |
Primary outcome
Proportion of Trichophyton isolates with elevated terbinafine MIC
Time frame: Up to 7 weeks after specimen collection
Percentage of evaluable Trichophyton isolates with a terbinafine minimum inhibitory concentration (MIC) of 0.5 ug/mL or higher (study-defined elevated MIC), determined by CLSI M38 broth microdilution with an 80% inhibition endpoint, reported with a Wilson 95% confidence interval.
4 secondary outcomes
Terbinafine MIC distribution, range, MIC50 and MIC90
Time frame: Up to 7 weeks after specimen collection
Itraconazole MIC distribution, range, MIC50 and MIC90
Time frame: Up to 7 weeks after specimen collection
Species distribution of dermatophyte isolates
Time frame: Up to 4 weeks after specimen collection
Association of elevated terbinafine MIC with clinical variables
Time frame: Up to 7 weeks after specimen collection
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 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. De-identified aggregate results will be reported in publications; individual data may be made available on reasonable request to the principal investigator.
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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.
Kalsoom Jawaid, MBBS, FCPS, CMT principal investigator
Faisalabad Medical University
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 Dermatophytosis and Tinea Corporis, run by Dr. Amara Safdar at 1 site in Pakistan.
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 3 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: looking for participants now, as of the sponsor's last update on 27 Oct 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 Pakistan. 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 Kalsoom Jawaid, MBBS, FCPS, CMT (+923214470345, dr.klsmjwd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Trichophyton isolates with elevated terbinafine MIC (time frame: Up to 7 weeks after specimen collection). 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 27 Oct 2026.