Comparing the Efficacy of Oral Fluconazole Versus Oral Itraconazole in Treating Resistant Tinea Corporis

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.

Inclusion criteria

Adults aged 18-70 years

Male or female

Clinical diagnosis of resistant tinea corporis, defined as persistent disease ≥6 months despite topical antifungal therapy

Microscopic confirmation of fungal hyphae on KOH preparation of skin scrapings

Exclusion criteria

Prior use of oral antifungal therapy within the past 3 months

Recent antibiotic treatment for superadded bacterial skin infection in the past 1 month

Known immunosuppressive conditions (e.g., diabetes mellitus, malignancy)

Current or recent use of immunosuppressive drugs

Pregnant or lactating women