To assess the sensitization potential of skin care and hair care formulations on healthy human subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Safety assessment of products
研究概览
简要总结
Objective: The objective of this study is to evaluate the sensitization potential of Skin Care formulations on healthy human subjects
Population of 120 healthy subjects (60 males + 60 females)
The test area is checked for erythema and oedema caused due to the products.
T0, T2, T4, T7, T9, T11, T14, T16, T18 – Patch Application
T1, T3, T5, T8, T10, T12, T15, T17, T19 – Patch Removal
T2, T4, T6, T9, T11, T13, T16, T18, T20 - 24-hour post patch removal grading
14 DAYS RESTING PHASE
T21 – Patch Application
T22 – Patch Removal
T23 - 24 hour post patch removal grading
T24 - 48 hour post patch removal grading
T25 - 72 hour post patch removal grading
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
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) Subjects willing to come for regular follow up and ready to follow instructions during the study period.
排除标准
- •For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic, Being asthmatic, Having eczema, Poriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area), Having a rhinitis, allergic conjunctivitis or rhinosinusitis.
结局指标
主要结局
Safety assessment of products
时间窗: T0, T2, T4, T7, T9, T11, T14, T16, T18 – Patch Application | T1, T3, T5, T8, T10, T12, T15, T17, T19 – Patch Removal | T2, T4, T6, T9, T11, T13, T16, T18, T20 - 24-hour post patch removal grading | 14 DAYS RESTING PHASE | T21 – Patch Application | T22 – Patch Removal | T23 - 24 hour post patch removal grading | T24 - 48 hour post patch removal grading | T25 - 72 hour post patch removal grading
次要结局
未报告次要终点