Evaluation of irritation potential of Silever Face Wash through dermatological Evaluation by single occlusive patch test on Healthy adult human volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluation of mean scores of Erythema/dryness/wrinkles, Oedema and Mean Irritation Index
研究概览
简要总结
24adulthealthy subjects will be selected for the study. The subjects selected for thisstudy will be healthy females and males, aged between 18 and 55 years old. In which 12 willbe females and 12 will be male subjects. The entire study procedure, patchapplication, patch reading and grading is detailed in the protocol and followedas per the protocol. The Patch applied contain Finn’s chamber within which 2drops of the test product will be filled in a separate chamber.The patch is applied on the back or shoulder area of the subjects and will bein contact with the skin for 24 hours. If the subject experiences any allergicreaction, the patch can be removed within 24 hours and reported to theinvestigator immediately. The mean scores of Erythema/dryness/wrinkles, Oedema and MeanIrritation Index will be calculated on day 1,2,3 and 8.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subjects with healthy skin on the studied anatomic unit (free of eczema, wounds & any other inflammatory scar)
- •Age group of 18 to 55 years, 12 male and 12 female subjects.
- •Compliance with the study procedures involved.
排除标准
- •1.Pregnant and lactating women 2.Subjects with any other skin disorders.
- •3.Use of any other topical agents for any skin related conditions (at the site of application of patch) during the past 30 days.
结局指标
主要结局
Evaluation of mean scores of Erythema/dryness/wrinkles, Oedema and Mean Irritation Index
时间窗: Day 1,2,3 and 8
次要结局
- occurrence of any adverse effects.(day 1,2,3 and 8)