The objective of this study will be to evaluate the irritation potential on healthy human subjects having Varied skin types of skin & hair care formulations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Dermatological safety / Irritation potential on skin
研究概览
简要总结
Objective: The objective of this study will be to evaluate the irritation potential on healthy human subjects having Varied skin types of Skin & Hair Care Formulations
Duration of study: 8 days 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: 26 healthy subjects (13 males + 13 females) with varied skin types.
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
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Human Subjects 2) Skin should be 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.
- •Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination).
排除标准
- •1 For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give his/her assent by not signing the consent form 3 Taking part in another study liable to interfere with this study 4 Being diabetic.
- •5 Being asthmatic.
- •6 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •7 Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
- •8 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •9 Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
- •10 Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
结局指标
主要结局
Dermatological safety / Irritation potential on skin
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
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.