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

NCT07342153 | Recruiting Phase 4

• 1 other identifier: IRB-89-6/2/25
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinea Corporis; Dermatophytosis

Keywords

Tinea Corporis; Dermatophytosis; Antifungal Resistance; Fluconazole; Itraconazole; Randomized Controlled Trial; Pakistan

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Clinical Resolution of Resistant Tinea Corporis

  Clinical resolution is defined as the absence of erythema (score 0), scaling (score 0), and pruritus (score 0) using the Dermatophyte Severity Scale and a patient-reported visual analog scale, with no visible skin lesions. Clinical assessment will be performed by a consultant dermatologist, and pruritus will be graded by participants.

  4 weeks after initiation of assigned treatment

Study Arms (2)

Itraconazole Group

EXPERIMENTAL

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).

Drug: Itraconazole (200 mg)

Fluconazole Group

ACTIVE COMPARATOR

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).

Drug: Fluconazole 150 mg

Interventions

Itraconazole (200 mg) 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.

Also known as: Sporanox, Arm 1

Itraconazole Group

Fluconazole 150 mg 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.

Also known as: Diflucan

Fluconazole Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Urooj Fatima: lead

Study Sites (1)

CDA Hospital Islamabad

Islamabad, Punjab Province, 46000, Pakistan

RECRUITING

Related Links

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

MeSH Terms

Conditions

Tinea

Interventions

Itraconazole; Fluconazole

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Urooj Fatima, MBBS

  Capital Development Authority (CDA) Hospital Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urooj Fatima, MBBS

CONTACT

+923363005069; urooj29scorpio@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator (Postgraduate Resident, Dermatology)

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: January 15, 2026
• Study Start: November 1, 2025
• Primary Completion: February 20, 2026
• Study Completion: March 10, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)