Evaluation of irritation potential of SileverShampoo through dermatological Evaluationby single occlusive patch test on Healthyadult human volunteers
试验速览
- 阶段
- 2/3 期
- 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
研究概览
简要总结
24 adult healthy subjects will be selected for the study. The subjects selected for the study will be healthy females and males, aged between 18 and 55 years old, in which 12 will be females and 12 will be male subjects. The entire study procedure, patch application, patch reading and grading is detailed in the protocol and followed as per the protocol. The patch applied contain Finn’s Chamber within which 2 drops 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 be in contact with skin for 24 hours. If the subject experiences any allergic reaction, the patch can be removed within 24 hours and reported to the investigator immediately. The mean score of Erythema/ dryness/ wrinkles. Oedema and Mean Irritation Index will be calculated on day 1,2,3 and 8
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
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
- •Pregnant and lactating women
- •Subjects with any other skin disorders.
- •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
时间窗: Day 1,2,3 and 8
irritation index
时间窗: Day 1,2,3 and 8
Erythema/dryness/wrinkles, Oedema and Mean
时间窗: Day 1,2,3 and 8
次要结局
- occurrence of any adverse effects(Day 1,2,3 and 8)