Comparison of Topical 2 percent Luliconazole vs Topical 2 percent Naftifine in patients of Tinea Cruris and or Tinea Corporis an Open level Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Clinical response in the form of clinical and mycological cure by changes in erythema , scaling , pruritis in tinea corporis and /or tinea cruris after 28 days of treatment and at the end of 42 days in both groups
研究概览
简要总结
This study aims to compare the efficacy of topical luliconazole and topical naftifine in the treatment of patients diagnosed with tinea cruris and or tinea corporis . Diagnosis is based on clinical response and mycological cure rate. Topical naftifine and topical luliconazole are the drugs for the therapeutic option due to their efficacy , safety and minimal side effects. An open label interventional study participants included will be all the patients in the age group of 18 years or above based on predefined inclusion and exclusion criteria. Primary outcome variables are clinical response and mycological cure rate. Sample size has been calculated using N master software .The total sample size would be 130 participants.
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.Patients presenting with clinical signs and symptoms consistent with Tinea Cruris and or Tinea Corporis 2.Laboratory confirmation of dermatophyte infection by positive potassium hydroxide microscopy.
排除标准
- •1.Pregnant or breastfeeding women 2.Individuals who are immunocompromised or have uncontrolled diabetes mellitus 3.Participation in another investigational drug or clinical trial within the past 30 days.
结局指标
主要结局
Clinical response in the form of clinical and mycological cure by changes in erythema , scaling , pruritis in tinea corporis and /or tinea cruris after 28 days of treatment and at the end of 42 days in both groups
时间窗: Clinical response in the form of clinical and mycological cure by changes in erythema , scaling , pruritis in tinea corporis and /or tinea cruris after 28 days of treatment and at the end of 42 days in both groups
次要结局
- Adverse Events(4 weeks & 6 weeks)
研究者
Rupam Roy
Agartala Government Medical College and GBP Hospital