To evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types
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
- To evaluate the dermatological safety of
研究概览
简要总结
Single Application Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Objective : To evaluate the dermatological safety of investigational products by primary
irritation patch test on healthy human volunteers of varied skin types.
Duration of study: 8 days study
**Kinetics: T0 (**Evaluation of test sites by Dermat and Subject,
Patch application), T1(Patch removal - 30 minutes acclimatization, Evaluation of test sites by Dermat and Subject post 30 minutes of patch removal), 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) The subjects are selected on the basis of skin types:
3 males + 3 females for dry skin
3 males + 3 females for oily skin
3 males + 3 females for combination skin
3 males + 3 females for normal skin
Products : Shampoo (17821), Face Wash (FAPM 61/07),Face Wash (FAPM 61/16),Face Wash (TSP 56-194B), Shower Gel( TSP 56-197A) ,Soap(FG-5064)
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
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 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
To evaluate the dermatological safety of
时间窗: T0 (before patch application, T1(0 hours after | patch removal), T2(24 hours of patch removal, T8 (T+1 week after 0 hours of patch removal
investigational products by primary irritation
时间窗: T0 (before patch application, T1(0 hours after | patch removal), T2(24 hours of patch removal, T8 (T+1 week after 0 hours of patch removal
patch test on healthy human volunteers of varied
时间窗: T0 (before patch application, T1(0 hours after | patch removal), T2(24 hours of patch removal, T8 (T+1 week after 0 hours of patch removal
skin types
时间窗: T0 (before patch application, T1(0 hours after | patch removal), T2(24 hours of patch removal, T8 (T+1 week after 0 hours of patch removal
次要结局
- Not Applicable(Not Applicable)