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
- To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test
研究概览
简要总结
Itis a primary irritation patch test under dermatological control. A patch testunder occlusion is carried out using IQ Chambers an inside area of 9X9mm (81mm2)followed by assessment using Draize scale scoring.
24 healthy human volunteers will be enrolled into the study. Study duration is 9 days for each subject.
Therequired quantity of sample (as updated in the Investigational product manual)will be put on chambers prefixed on tape.
This patch will thenbe applied on the test site i.e. between the scapulae and waist of thesubjects. The patch will be kept for 24hours. After which the patches will be removed and the first observation willbe made at 30 minutes of patch removal (24 hr reading). The further observationswill be at 48 hr and 7th day post patch application.
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
- •Subjects age group
- •55 years. Healthy male & female volunteers. Subjects with skin type III to V. Subjects willing to give a written informed consent. 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. Subjects willing to come for regular follow up. Subjects ready to follow instructions during the study period.
排除标准
- •Infection, allergy on the tested area History of skin allergy antecedents or atopic subjects History of 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.
- •Subjects on oral corticosteroid with dose >10mg/day Subjects participating in any other cosmetic or therapeutic trial.
- •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
To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test
时间窗: 24 hours, 48 hours and 7 days post patch removal.
次要结局
未报告次要终点