Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy 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
- The objective of this study is to evaluate the dermatological safety of the given investigational products on healthy human volunteers.
研究概览
简要总结
Objective:
The objective of this study is to evaluate the dermatological safety of the given investigational products on healthy human volunteers.
Subject Population:
24 healthy human volunteers (Male and Female 1:1)
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.
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
- •â€¢Subjects age group 18-55 years •Healthy male & female volunteers •Subjects with skin type III to V.
- •â€¢Subjects willing to give a written informed consent.
- •â€¢Subjects willing to maintain the patch test in position for 24 hours •Subject has not participated in a similar investigation in the past two weeks.
- •â€¢Subjects willing to come for regular follow up.
- •â€¢Subjects ready to follow instructions during the study period.
排除标准
- •â€¢Infection, allergy on the test site •Skin allergy antecedents or atopic subjects •Hyper sensitivity to any component of the tested products •Athletes and subjects with history of excessive sweating •Cutaneous disease which may influence the study result •Chronic illness which may influence the cutaneous state.
- •â€¢Subjects on oral corticosteroid with dose >10mg/day •Subjects participating in any other cosmetic or therapeutic trial.
- •â€¢Any history of underlying uncontrolled medical illness including diabetes, hypertension, 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 given investigational products on healthy human volunteers.
时间窗: The objective of this study is to evaluate the dermatological safety of the given investigational products on healthy human volunteers.
次要结局
未报告次要终点