An observational study in Dermatophytosis, Tinea Corporis and Tinea Cruris, sponsored by Dr. Amara Safdar. Recruiting at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Dr. Amara Safdar · Observational
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.
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.
91 studies on the registry are indexed under Tinea; 7 are open to participants now.
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Consecutive patients attending the dermatology outpatient department of Allied Hospital, Faisalabad Medical University, Faisalabad, Pakistan, with clinically suspected, KOH-confirmed dermatophytosis.
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Exclusion Criteria:
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.
Other: In vitro antifungal susceptibility testing
Broth microdilution (CLSI M38) testing of each fungal isolate against terbinafine and itraconazole. Laboratory test on specimens only; patient treatment is not altered.
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.
Time frame: Up to 7 weeks after specimen collection
Terbinafine MIC distribution, range, MIC50 and MIC90
Terbinafine MIC values (ug/mL) of all dermatophyte isolates, reported by species.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to 7 weeks after specimen collection
Plan to share: 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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Started Oct 2026 (actual). Primary completion is estimated for Apr 2027, 6 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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