"A Comparative study to evaluate the efficacy and safety of topical Luliconazole versus topical Ciclopirox olamine among patients with Tinea corporis/cruris"
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Primary effectiveness is assessed based on percentage of patients achieving complete clearance. Complete clearance is defined as achieving both clinical response and mycological cure.
研究概览
简要总结
Topical antifungal drugs are commonly employed in Tinea corporis/cruris.
Several tertiary centers frequently prescribe luliconazole for its broad spectrum and anti-inflammatory property. It is expensive, and relapse are documented.
There is need of antifungals with diverse modes of action, as well as those that are affordable and less risk of relapse.
Ciclopirox olamine inhibits enzymes necessary for fungal cellular activity. It has additional antibacterial properties which help treating superadded infections.
There are very few studies comparing Luliconazole and ciclopirox olamine in the treatment of Tinea corporis/cruris in India.
Hence this study is undertaken to compare Luliconazole versus ciclopirox olamine in the treatment of Tinea corporis and cruris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •Patients willing to give informed consent and follow up.
- •Patients of either gender aged between 18-60 years.
- •Patients with mild Tinea corporis or cruris and Positive KOH Test.
排除标准
- •Patients with hypersensitivity to study medications.
- •Patients with deep fungal infections.
- •Patients with Tinea unguim, Tinea capitis and Tinea barbae.
- •Psychiatric or emotional disturbance in patients.
- •Diabetic and Immunocompromised patients.
结局指标
主要结局
Primary effectiveness is assessed based on percentage of patients achieving complete clearance. Complete clearance is defined as achieving both clinical response and mycological cure.
时间窗: 0,2,4 weeks
Clinical response is assessed using investigator global evaluation tool based on signs and symptoms which give score ranging from 1 to 5.Where score 1:Healed(absence of signs and symptoms),
时间窗: 0,2,4 weeks
score 2:markedly improved greater than 50% clinical improvement, score 3:considerable residual lesion(less than 50% clinical improvement),score 4(no change from baseline),score 5 :deterioration from baseline .Clinical response will be defined as having scores 1 or 2 (healed or markedly improved)
时间窗: 0,2,4 weeks
Mycological cure is defined by achievement of negative result on KOH mount at the end of the treatment period.
时间窗: 0,2,4 weeks
Change in Total symptom score.
时间窗: 0,2,4 weeks
次要结局
- Safety is assessed by adverse drug reactions which will be reported in CDSCO form and severity grading will be done.(0,2,4th week)
研究者
Praveen Panchaksharimath
Bangalore Medical College and Research Institute