Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects
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.
Subject Population:
24 healthy human volunteers.
Duration of study:
Approximately 9 days for each volunteer
The required quantity of the sample will be put on the upper back of subjects and closed with IQ chambers prefixed on tape.
This patch will then be applied on the test site i.e. between the scapulae and waist of the subjects. The patch will be kept for 24 hours. After which the patches will be removed and the first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hr and 1 week of patch removal.
Results:Investigational products 1-8 emerged as non irritant products when observed at 0hr, 24 hrs and 7 days post patch removal. Positive control was confirmed as irritant when observed at 0hr and 24 hrs post patch removal and was non irritant when observed at day 7 post patch removal.
The assessment was done as per Draize scale for scoring irritation mentioned in Clause 4.3.1.3 in IS 4011:1997 Methods of test for safety evaluation of cosmetics, reaffirmed (2004), Edition 3.2 (2007-11), second revision (ICS 71.100.40), clause 4.3.1,4.3.1.2 BIS 2008 at 0hr, 24hrs and day7 post patch removal readings
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1Subjects in age group
- •55 years. 2Healthy male & female subjects. 3.Subjects with Fitzpatrick skin type III to V. 4.Subjects willing to give a written informed consent. 5.Subjects willing to maintain the patch test in position for 24 hours. 6.Subject having not participated in a similar investigation in the past two weeks. 7.Subjects willing to come for regular follow up visits. 8.Subjects ready to follow instructions during the study period. 9.Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-I and by dermatological evaluation for the confirmation of the same.
排除标准
- •â€¢Infection, allergy on the tested area.
- •â€¢Skin allergy antecedents or atopic subjects.
- •â€¢Athletes and subjects with history of excessive sweating.
- •â€¢Cutaneous disease which may influence the study result.
- •â€¢Subjects on oral corticosteroid >10mg/day.
- •â€¢Subjects participating in any other cosmetic or therapeutic study.
- •â€¢Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
结局指标
主要结局
The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects
时间窗: 0hr,24hr and 7days post patch removal
次要结局
未报告次要终点