CTRI/2019/07/020160已完成不适用
Evaluation of Dermatological Safety of Investigational Products by Primary Irritation Patch Test on Healthy Human Volunteers with sensitive skin of varied skin types
ITC Life Sciences Technology Centre1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年7月22日最近更新:
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
- Safety assessment of products
研究概览
简要总结
Objective: To evaluatethe irritation potential on healthy human subjects of Skin CareFormulations.
Duration of study: 8 days study
Kinetics: T0 (Evaluation oftest sites by Dermatologist, Patch application)
T1(Patchremoval, Evaluation of test sites by Dermatologist
T2(Evaluationof test sites by Dermatologist and Subject post 24 hrs of patchremoval),
T8 (Evaluation of testsites by Dermat and Subject post 1 week of patch removal and tracking thepositive cases)
Population 24 healthy subjects(12 males + 12 females)
The test area is checked forerythema and oedema caused due to the products and compared with positivecontrol.
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 representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and combination) 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 & 7 days
次要结局
- Not Applicable(Not Applicable)
研究者
研究点 (1)
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