NCT02400320撤回4 期
Cumulative Skin Irritation Study Evaluating the Skin Irritancy Potential of Topical Analgesic Vovilup Spray Containing a Combination of Diclofenac, Menthol, Methyl Salicylate and Linseed Oil and Comparing it With a Marketed Formulation - Iodex Ultragel
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Mean cumulative irritation score
研究概览
简要总结
The purpose of this study is to determine local skin safety of a topical analgesic spray containing a combination of diclofenac, methyl salicylate, menthol and compare it with a topical analgesic gel containing a combination of diclofenac, methyl salicylate, and menthol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Topical Spray
Active Comparator
Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%.
干预措施: Topical Spray (Drug)
Topical Gel
Experimental
Topical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10%
干预措施: Topical Gel (Drug)
Saline
Other
Saline
干预措施: Saline (Other)
结局指标
主要结局
Mean cumulative irritation score
时间窗: 7 days
次要结局
未报告次要终点
研究者
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