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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUrooj Fatima

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Itraconazole GroupExperimental treatment 1 intervention
Group B: Fluconazole GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
4 weeks after initiation of assigned treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Urooj Fatima

Lead sponsor

Capital Development Authority (CDA)

Sponsor institution