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

NCT ID: NCT07342153

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-03-10

Brief Summary

Tinea corporis (commonly called "ringworm of the body") is a skin infection caused by fungi that often becomes difficult to treat when it persists despite creams or other medicines. In recent years, many patients have developed infections that do not respond to routine antifungal treatments, which causes long-term itching, redness, and scaling of the skin.

This study will test two commonly used oral antifungal drugs - fluconazole and itraconazole - in people with resistant tinea corporis. Adults aged 18-70 years who have had persistent disease for at least six months will be enrolled at the Dermatology Department of CDA Hospital, Islamabad.

Participants will be randomly assigned to one of two groups. One group will receive itraconazole 200 mg once daily for four weeks, and the other group will receive fluconazole 150 mg every other day for four weeks. Neither group will know which medicine they are receiving (blinded allocation).

The main goal is to find out which medicine works better in achieving complete clinical resolution - meaning no redness, no scaling, no itching, and no visible skin lesions - after four weeks of treatment. Doctors will measure the severity of symptoms using a standard scoring system, and patients will also report their level of itching.

The findings will help guide doctors in Pakistan and similar regions in choosing the most effective oral antifungal for patients with resistant tinea corporis, improving both treatment success and patient quality of life.

Detailed Description

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.

Conditions

Tinea Corporis; Dermatophytosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Itraconazole Group

Participants in this arm will receive oral itraconazole 200 mg once daily for 4 weeks. Treatment will be administered at the Dermatology Department, CDA Hospital, Islamabad. Clinical outcomes will be assessed at the end of therapy using standardized severity scores (erythema, scaling, and pruritus).

Group Type: EXPERIMENTAL

Itraconazole (200 mg)

Intervention Type: DRUG

Oral itraconazole 200 mg once daily for 4 weeks. Assigned to participants in the Itraconazole Group. FDA-approved antifungal drug being evaluated for comparative effectiveness in resistant tinea corporis.

Fluconazole Group

Participants in this arm will receive oral fluconazole 150 mg on alternate days for 4 weeks. Treatment will be administered at the Dermatology Department, CDA Hospital, Islamabad. Clinical outcomes will be assessed at the end of therapy using standardized severity scores (erythema, scaling, and pruritus).

Group Type: ACTIVE_COMPARATOR

Fluconazole 150 mg

Intervention Type: DRUG

Oral fluconazole 150 mg every other day for 4 weeks. Assigned to participants in the Fluconazole Group. FDA-approved antifungal drug being evaluated for comparative effectiveness in resistant tinea corporis.

Interventions

Itraconazole (200 mg)

Oral itraconazole 200 mg once daily for 4 weeks. Assigned to participants in the Itraconazole Group. FDA-approved antifungal drug being evaluated for comparative effectiveness in resistant tinea corporis.

Intervention Type: DRUG

Fluconazole 150 mg

Oral fluconazole 150 mg every other day for 4 weeks. Assigned to participants in the Fluconazole Group. FDA-approved antifungal drug being evaluated for comparative effectiveness in resistant tinea corporis.

Intervention Type: DRUG

Other Intervention Names

Sporanox; Arm 1; Diflucan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Urooj Fatima

OTHER

Sponsor Role: lead

Responsible Party

Urooj Fatima

Principle Investigator (Postgraduate Resident, Dermatology)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Urooj Fatima, MBBS

Role: PRINCIPAL_INVESTIGATOR

Capital Development Authority (CDA) Hospital Islamabad

Locations

CDA Hospital Islamabad

Islamabad, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Urooj Fatima, MBBS

Role: CONTACT

urooj29scorpio@gmail.com

+923363005069

Facility Contacts

CDA Hospital, Islamabad

Role: primary

contactus@cda.gov.pk

+92 519221334

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.myhospitalnow.com/hospitals/cda-hospital

Capital Development Authority (CDA) Hospital, Islamabad - Institutional Information

Other Identifiers

IRB-89-6/2/25

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-89-6/2/25

Identifier Type: -

Identifier Source: org_study_id