Evaluation of dermatological safety and adverse reaction of Entice Glow Moisturizer for dermatological safety by 24 hrs patch test under complete occlusion on healthy human subjects..
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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 product/s on skin of healthy human volunteers by dermatological visual assessment
研究概览
简要总结
The patch test is the most common technique to evaluate a product tolerance on human skin. There are various methods of patch test which differ on the study objectives. The most common method is single application occlusive patch test for 24 hrs followed by observation after 48 hrs after application also. This method is a very common method in dermatological & inhalation practice to evaluate any intolerance which can result in acute dermatitis.
The current study objective isevaluation of dermatological safety and adverse reaction of Entice GlowMoisturizer for dermatological safety by 24 hrs patch test under completeocclusion on healthy human subjects.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects in age group
- •55 years (both the ages inclusive). 2.Healthy 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 one month. 7.Subjects willing to come for regular follow up visits. 8.Subjects ready to follow instructions during the study period. Test period:9 days for all subjects including screening day.
排除标准
- •1.Infection, allergy on the tested area.
- •2.Skin allergy, antecedents or atopic subjects.
- •3.Athletes and subjects with history of excessive sweating.
- •4.Cutaneous disease which may influence the study result.
- •5.Subjects on oral corticosteroid .
- •6.Subjects participating in any other cosmetic or therapeutic study.
- •7.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 given investigational product/s on skin of healthy human volunteers by dermatological visual assessment
时间窗: 24 hrs
次要结局
- Adverse event monitoring(0 hr to 24 hrs)