A comparative study to evaluate efficacy, safety and cost effectiveness between to evaluate efficacy, safety and topical 1% Butenafine vs topical 2% Sertaconazole in tinea infections of skin
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- a) Efficacy( 1. Change in baseline sign and symptom score 2. Change in Physicians Global Evaluation Response b). Safety (No. Of patients developing ADRs and type of ADRs) c). Cost effectivenes (Incremental cost and Incremental effectiveness)
研究概览
简要总结
This is " A randomized open label controlled comparative trial to evaluate the efficacy, safety and cost effectiveness between 2% Sertaconazole vs 1% butenafine in tinea infections of skin." This study was conducted at C.U. Shah Medical College, Dudhrej road, Surendranagar as a part of P.G. Thesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 13.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •New cases of tinea infections of skin from skin OPD.
排除标准
- •Follow up cases 2) Pregnant and Lactating women 3) patients having hypersensitivity to one of the antifungal agents used in the study.
结局指标
主要结局
a) Efficacy( 1. Change in baseline sign and symptom score 2. Change in Physicians Global Evaluation Response b). Safety (No. Of patients developing ADRs and type of ADRs) c). Cost effectivenes (Incremental cost and Incremental effectiveness)
时间窗: a) Efficacy( 1. Change in baseline sign and symptom score 2. Change in Physicians Global Evaluation Response b). Safety (No. Of patients developing ADRs and type of ADRs) c). Cost effectivenes (Incremental cost and Incremental effectiveness)
次要结局
- 1) Clinicomycological correlation(2)Relapse rate asssessment)