Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Outcome TimePoints
研究概览
简要总结
Study Objective:
The objective of thisstudy is to evaluate the dermatological safety of the investigational productson healthy human subjects.
Study Population:
24 healthy humanvolunteers (Male and Female 1:1) with Skin types (Oily, Dry, Normal andCombination, 1:1:1:1 ratio).
Duration of study:
Approximately 9 days foreach volunteer.
Test Site:
Between the scapula andwaist 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 systemis applied at the test site of study subjects starting with the lower edge ofthe patch system and slowly pressing upwards till the top edge in order tosqueeze out the air.
Patch Methodology:
The patch will be keptfor 24 hours. The patch will be removed after 24 hours. The test siteswill be wiped with a clean tissue to remove any residue prior toevaluation. Dermatologist will visually assess the skin condition of eachtest site at the following frequencies- 20-30 minutes’ post patch removal (0hour reading), 24 hrs and 7 days’ post patch removal as per Draize scoringsystem.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects in age group
- •65 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 voluntary 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 two weeks. 7.Subjects willing to come for regular follow up visits. 8.Subjects ready to follow instructions during the study period.
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 trial.
- •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
Outcome TimePoints
时间窗: Approximately 9 days for each subject.
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