Dermatophytes are filamentous fungi that infect keratinized tissues such as skin, hair,
and nails, and they are responsible for millions of infections worldwide each year. Among
these infections, tinea corporis (ringworm of the body) is common, but a growing problem
is the development of resistant and relapsing disease, where standard topical antifungal
agents fail to achieve lasting clearance. Contributing factors include host immune
status, environmental influences, and emerging antifungal resistance. Reports from
different geographic regions, including South Asia, indicate rising resistance to several
antifungal classes, creating a therapeutic challenge for clinicians.
Although oral antifungals such as fluconazole and itraconazole are widely used, previous
studies comparing their efficacy often included mixed dermatophyte infections and not
specifically resistant tinea corporis. Data from the local population is especially
limited, and differences in skin type and resistance patterns across regions further
highlight the need for context-specific evidence.
This randomized controlled trial will compare the efficacy of oral fluconazole and oral
itraconazole in adult patients (18-70 years) with resistant tinea corporis. Resistance is
defined as disease persisting for at least six months despite topical antifungal therapy,
confirmed by direct microscopic visualization of fungal hyphae in potassium hydroxide
(KOH)-treated skin scrapings.
Participants will be randomized into two groups:
Group A: Itraconazole 200 mg orally once daily for 4 weeks.
Group B: Fluconazole 150 mg orally on alternate days for 4 weeks.
The primary endpoint is complete clinical resolution at 4 weeks, defined as the absence
of erythema, scaling, and pruritus (all scored 0 on standardized scales), with no visible
skin lesions. Clinical assessment will be performed by a consultant dermatologist using
the Dermatophyte Severity Scale, while pruritus will be graded by participants using a
visual analog scale.
A total of 126 patients (63 per group) will be recruited, calculated using WHO sample
size formulas with assumptions based on published efficacy rates (84% for itraconazole vs
62% for fluconazole). Randomization will be done using a mobile randomizer application,
and patients will be blinded to the intervention received.
The study duration is six months from approval, conducted at the Dermatology Department
of CDA Hospital, Islamabad, under CPSP and institutional IRB oversight (IRB-89-6/2/25,
approved 06-Feb-2025). Data will be analyzed using SPSS v22, with categorical variables
compared by Chi-square or Fisher exact tests, and stratification for potential
confounders such as age, gender, BMI, and education. A p-value ≤0.05 will be considered
statistically significant.
This study is expected to provide reliable local evidence on the comparative
effectiveness of itraconazole versus fluconazole for resistant tinea corporis, guiding
clinical decision-making in Pakistan and other regions facing similar antifungal
resistance challenges.
