Evaluation of dermatological safety of investigational products by primary irritation patch test on subjects with sensitive skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Safety assessment of investigational products for
研究概览
简要总结
The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects with sensitive skin.Primary irritation patch test is used widely for the evaluation of safety of cosmetics in humans.
Sample Size :Thirty Five (male and female, in a nearly 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 (IS4011:1997) &IS 13424:2001
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
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 male and female subjects in the age group of 18-55 years(both age inclusive)
- •Subjects in good general health
- •Subjects with Fitzpatrick skin type III to V
- •Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumann’s skin type questionnaire
- •Subject identified to have sensitive skin basis dermatologist’s assessment of skin with fine texture and closeness of blood vessels to the surface
- •Subjects willing to give a voluntary written informed consent
- •Subjects willing to maintain the test patches in designated positions for 24 hours
- •Subjects having not participated in a similar investigation in the past eight weeks
- •Subjects willing to come for regular follow up visits
- •Subjects ready to follow instructions during the study period
- •Subjects without any open wounds, cuts, abrasions, irritation symptoms.
排除标准
- •Subjects with a present condition of allergic response to any cosmetic product
- •Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study
- •Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy)
- •Subjects with cutaneous disease that could interfere with the study results
- •Subjects with chronic illness that may influence the cutaneous state or any other illness including Diabetes, liver disease, HIV or any other serious medical illness
- •Subjects participating in any other cosmetic or therapeutic trial.
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 done on 0 | hour after patch removal, 24 hours after patch removal and 7 days post patch removal
irritation potential using Draize scale
时间窗: Safety assessment of investigational products for | irritation potential using Draize scale done on 0 | hour after patch removal, 24 hours after patch removal and 7 days post patch removal
次要结局
- Not Applicable(Not Applicable)