A comparative study to evaluate efficacy, safety and cost effectiveness between Whitfield’s ointment + oral Fluconazole vs topical 1% Butenafine in tinea infections of skin
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. Change in baseline sign and symptoms score
研究概览
简要总结
Thisstudy is a randomized, open label parallelgroup, trial comparing the efficacy, safety and cost effectiveness betweenWhitfield’s ointment + Oral Fluconazole vs. 1% butenafine in tinea infectionsof skin. The primary outcome measures were the efficacy a. Efficacy (1. Changein baseline sign and symptoms score 2. Change in Physician’s Global EvaluationResponse b. Safety (No. of ADRs developed & percentage of the participantsdeveloping ADRs) c. Cost effectiveness (Incremental cost and Incrementaleffectiveness) over one month. The secondary outcomes were1) Assessment ofclinico mycological correlation2)Comparison of relapse rate with both thetreatments 3)To identify and find the prevalence of different species of tinea
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •New patients attending skin O.P.D.
排除标准
- •Follow up cases 2) pregnant or lactating women, 3) patients having allergy to topical imidazole or any other antifungals used in the study.
结局指标
主要结局
1. Change in baseline sign and symptoms score
时间窗: one month
2. Change in Physician’s Global Evaluation Response
时间窗: one month
b. Safety (No. of ADRs developed & percentage of the participants developing ADRs)
时间窗: one month
c. Cost effectiveness (Incremental cost and Incremental effectiveness)
时间窗: one month
次要结局
- 1. Assessment of clinico mycological correlation(2.Comparison of relapse rate with both the treatments)