Evaluation of irritation potential of Skin Care Formulations 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
- To evaluate the irritation potential on healthy human subjects of Skin Care Formulations.
研究概览
简要总结
Single Application, semi occlusive, Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin.
Objective: To evaluate the irritation potential on healthy human subjects of Skin Care Formulations.
Duration of study: 8 days study
**Kinetics: T0 (**Evaluation of test sites by Dermat and Subject,
Patch application)
**T1(**Patch removal, Evaluation of test sites by Dermat
T2(Evaluation of test sitesby Dermat and Subject post 24 hrs of patch removal),
T8 (Evaluation of test sitesby Dermat and Subject post 1 week of patch removal and tracking the positive cases)
Population 24 healthy subjects(12 males + 12 females)
**Products :**Deodorant Brand Name: SKORE(SD-002), Deodorant Brand Name: SKORE(SD-006), Deodorant Brand Name: SKORE(SD-007), Deodorant Brand Name: SKORE(SD-008), Deodorant Brand Name: SKORE(SD-009), Pocket Perfume Brand Name: SKORE(SPP-001), Pocket Perfume Brand Name: SKORE(SPP-002), Orgasmic Gel
Brand Name: SKORE OH! (SOG-17)
Positive control : 3% SLS
Negative Control :Distilled Water
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
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 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, 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
To evaluate the irritation potential on healthy human subjects of Skin Care Formulations.
时间窗: T0 (Evaluation of test sites by Dermatologist and Subject, | 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 Dermatologist and Subject post 1 week of patch removal and tracking the positive cases). | Formulations.
次要结局
- Not Applicable(Not Applicable)