Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects
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 investigational products on healthy human subjects
研究概览
简要总结
Study Objective:
The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects.
Study Population:
24 healthy human volunteers (Male and Female 1:1) with Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio).
Duration of study:
Approximately 9 days for each volunteer.
Test Site:
Between the scapula and waist of the subjects, the test site should be free of pigmentation, pimple, hair, mole or any dermatological condition that can interfere with the reading.
Patch Application:
The loaded patch system is applied at the test site of study subjects starting with the lower edge of the patch system and slowly pressing upwards till the top edge in order to squeeze out the air.
Patch Methodology:
The patch will be kept for 24 hours. The patch will be removed after 24 hours. The test sites will be wiped with a clean tissue to remove any residue prior to evaluation. Dermatologist will visually assess the skin condition of each test site at the following frequencies- 20-30 minutes’ post patch removal (0 hour reading), 24 hrs and 7 days’ post patch removal as per Draize scoring system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in age group
- •65 years (both the ages inclusive).
- •Healthy male & female subjects with skin types as defined in the population details under appendix
- •Subjects with Fitzpatrick skin type III to V
- •Subjects in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
- •Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- •Subjects willing to give a voluntary written informed consent.
- •Subjects willing to maintain the patch test in position for 24 hours.
- •Subject having not participated in a similar investigation in the past two weeks.
- •Subjects willing to come for regular follow up visits.
- •Subjects ready to follow instructions during the study period.
排除标准
- •Subjects with infection, allergy on the tested area.
- •Subjects with skin allergy, antecedents or atopic subjects.
- •Athletes and subjects with history of excessive sweating.
- •Subjects with cutaneous disease which may influence the study result.
- •Subjects on oral corticosteroid.
- •Subjects participating in any other cosmetic or therapeutic trial.
- •Subjects who are currently pregnant or lactating or planning to become pregnant in the period of study.
- •Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
- •Subjects working with MSCR.
结局指标
主要结局
To evaluate the dermatological safety of the investigational products on healthy human subjects
时间窗: Approximately 9 days for each subject.
次要结局
未报告次要终点