Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of sensitive skin types
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Dermatological safety / Irritation potential on skin
研究概览
简要总结
Single Application, occlusive, Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin.
Objective: To evaluate the dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of sensitive skin types.
Duration of study: 8 days study
**Kinetics: T0 (Evaluation of test sites by Dermat and Subject, Patch application),**T on evaporation of products, T+30mins post patch application, T1(Patch removal, 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 35 healthy subjects(17/18 males + 17/18 females).**The subjects selected for this study are healthy females and males, aged between 18 and 65 years old with sensitive (by Dr. Baumann’s Questionnaire & by Dermatologist’s Assessment of skin with closeness of blood vessels to the surface) & varied skin type. In which 17/18 will be female and 17/18 will be male subjects.
The distribution of volunteers as per skin type will be as follows:Oily skin – 5 Females + 5 MalesNormal skin – 4/5 Females + 5/4 MalesDry skin – 4 Females + 4 MalesCombination skin – 4 Females + 4 Males
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 sensitive skin type and varied skin type (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
- •Subject identified to have sensitive skin basis Dermatologist’s assessment of skin with closeness of blood vessels to the surface.
排除标准
- •For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three month.
- •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).
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