Comparing the Efficacy of Oral Fluconazole Versus Oral Itraconazole in Treating Resistant Tinea Corporis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving Clinical Resolution of Resistant Tinea Corporis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Itraconazole (200 mg) (Drug)
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).
干预措施: Fluconazole 150 mg (Drug)
结局指标
主要结局
Number of Participants Achieving Clinical Resolution of Resistant Tinea Corporis
时间窗: 4 weeks after initiation of assigned treatment
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.
次要结局
未报告次要终点
研究者
Urooj Fatima
Principle Investigator (Postgraduate Resident, Dermatology)
Capital Development Authority (CDA)