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
- 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
Objective:To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test Subject Population: 24 Healthy Human Volunteers (Male and Female). Duration of Study: 5 Visits (9 Days for each volunteer) **Inclusion Criteria:**1. Subjects age group 18 - 55 years
2. Healthy male & female volunteers
3. Subjects with skin type III to V.
4. Subjects willing to give a written informed consent.
5. Subjects willing to maintain the patch test in positionfor 24 hours
6. Subjecthas not participated in a similar investigation in the past two weeks.
7. Subjects willing to come for regular follow up.
8. Subjects ready to follow instructions during the studyperiod.
1. Infection, allergy on the testedarea
2. History of skin allergyantecedents or atopic subjects
3. History of hyper sensitivity toany component of the tested products
4. Athletes and subjects with history of excessive sweating
5. Cutaneous disease which mayinfluence the study result
6. Chronic illness whichmay influence the cutaneous state.
7. Subjects on oral corticosteroid with dose >10mg/day
8. Subjects participating in anyother cosmetic or therapeutic trial.
Exclusion Criteria:
1. Infection, allergy on the testedarea
2. History of skin allergyantecedents or atopic subjects
3. History of hyper sensitivity toany component of the tested products
4. Athletes and subjects with history of excessive sweating
5. Cutaneous disease which mayinfluence the study result
6. Chronic illness whichmay influence the cutaneous state.
7. Subjects on oral corticosteroid with dose >10mg/day
8. Subjects participating in anyother cosmetic or therapeutic trial.
9. Any history of underlyinguncontrolled medical illness including diabetes, liver disease or history ofalcoholism, HIV or any other serious medical illness.
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 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 4)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 2)History of skin allergy antecedents or atopic subjects 3)History of hyper sensitivity to any component of the tested products 4)Athletes and subjects with history of excessive sweating 5)Cutaneous disease which may influence the study result 6)Chronic illness which may influence the cutaneous state.
- •Subjects on oral corticosteroid with dose >10mg/day 8)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: To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test on Day 1, Day 2 & Day 7 of post patch application.
次要结局
- To gather safety information prior to a pilot study and/or larger study, in order to improve the latter’s quality and efficiency of the study design.(Dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test on Day 1, Day 2 & Day 7 of post patch application.)