CTRI/2020/10/028452已完成不适用
Evaluation of irritation potential of Skin Care formulation on healthy human subjects
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
- Safety assessment of products
研究概览
简要总结
bjective: To evaluate the irritation potential on healthy human subjects of Skin Care Formulations.
Duration of study: 8 days of study
Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application)
T1(Patch removal, Evaluation of test sites by Dermatologist
T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal),
T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases)
Population of 24 healthy subjects (12 males + 12 females)
The test area is checked for erythema and oedema caused due to the products and compared with positive control.
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
- •emale and male Asian Indian subjects.Healthy human subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 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, oriasis, 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: Baseline,0 hrs,24 hrs and 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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