Evaluation of dermatological safety of test products by primary irritation patch test on healthy human volunteers of varied skin types
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
- Safety assessment of investigational products for
研究概览
简要总结
Objective:
The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects. A primary irritation patch test is used widely for the evaluation of the safety of cosmetics in humans.
Sample Size: Twenty four (male and female, in a nearly equal ratio of 1:1) adult subjects in the age group of 18 years to 55 years (both inclusive)
Primary skin irritation results from reversible inflammatory changes in the skin following the application of a test substance.
By this test, irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs and is done as per BIS standard (BIS4011:2018)
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
- •1.Healthy male and female subjects in the age group of 18-55 years(both age inclusive)
- •Subject is having valid proof of identity and age
- •Subjects with skin phototype III to V 4.Subject is having apparently healthy skin on test area 5.Subject representing normal, oily, dry and combination skin type in nearly equal ratio
- •Subject willing to give a voluntary written informed consent
- •Subject willing to maintain the test patches in designated positions for 24 Hours
- •Subject willing to come for regular follow up visits
- •Subject ready to follow instructions during the study period
- •Subject without any open wounds, cuts, abrasions, irritation symptoms.
排除标准
- •Subjects with Known hypersensitivity to any of the study products or constituents
- •Subjects having any significant pathology in the test area
- •Subjects with any kind of skin allergy, antecedents or cutaneous disease which may influence the study results
- •Subjects having topical or systemic treatment in last month prior to participation in the study and during the study that could interfere with the study treatments/ assessments
- •Athletes and subjects with history of excessive sweating
- •Subject is Pregnant or Lactating
- •Subject with any significant medical condition that would interfere with the participation in the trial
- •Subjects participated in any other cosmetic or therapeutic trial or in a similar investigation
- •Subject is having Scars, excessive terminal hair or tattoo on the studied area.
结局指标
主要结局
Safety assessment of investigational products for
时间窗: Safety assessment of investigational products for | irritation potential using Draize scale after patch | removal at day 3, day 4 and 7 days post patch removal.
irritation potential using Draize scale after patch
时间窗: Safety assessment of investigational products for | irritation potential using Draize scale after patch | removal at day 3, day 4 and 7 days post patch removal.
removal at 0 hours(day 3),24 hours(day 4) and 7 days post
时间窗: Safety assessment of investigational products for | irritation potential using Draize scale after patch | removal at day 3, day 4 and 7 days post patch removal.
patch removal.
时间窗: Safety assessment of investigational products for | irritation potential using Draize scale after patch | removal at day 3, day 4 and 7 days post patch removal.
次要结局
未报告次要终点