Comparative study of efficacy and safety of Superbioavailable Itraconazole(SBITZ130) and conventional Itraconazole(CITZ 200) in patients with dermatophytosis in a tertiary care hospital: A Randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving complete cure (clinical + mycological) at end of treatment, assessed by Lesion Severity Score (LSS) and Area Severity Score (ASS).
研究概览
简要总结
This study is a comparative study of efficacy and safety of Superbioavailable Itraconazole(SBITZ130) and conventional Itraconazole(CITZ 200) in patients with dermatophytosis in a tertiary care hospital. It is an open label, prospective, double arm, parallel and single centered interventional study. The primary endpoint of the study will be to compare the percentage of patients achieving a complete cure (clinical cure plus mycological cure) at the end of the treatment period from baseline in both the groups. It will be assessed on the basis of the Lesion Severity Score (LSS) and the Area Severity Score (ASS). The Secondary outcome end point will be to assess the recurrence of dermatophytosis at the end of 10th week and safety of drugs used in both arms at 2nd , 4th and 6th week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Clinical diagnosis of dermatophytosis confirmed by direct microscopic examination of skin scrapings from the active border of the lesion after adding a drop of 10 percent potassium hydroxide solution 2 Had no prior history of using an oral antifungal in the previous four or a topical antifungal/steroid in the prior two weeks 3 Patient willing to participate in the study.
排除标准
- •1 Patients with extensive dermatophytosis, other forms of tinea infections, superadded bacterial infection 2 Patients taking concomitant medications that interact with itraconazole 3 Immuno-compromised patients and patients with co-morbid conditions like diabetes, CHF and liver dysfunction 4 Pregnant and lactating females 5 Patients with a history of hypersensitivity to azole antifungals 6 Patients who may require other antifungal drugs during the study period due to any other cause will be excluded from the study.
结局指标
主要结局
Percentage of patients achieving complete cure (clinical + mycological) at end of treatment, assessed by Lesion Severity Score (LSS) and Area Severity Score (ASS).
时间窗: Clinical Assessment at 2, 4 and 6 weeks.
次要结局
- Recurrence of dermatophytosis
- Safety of drugs used in trial(Assessed at 2, 4 and 6th week)
研究者
Dr Anu Gupta
Adesh University