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
- dermatological safety of
研究概览
简要总结
Single Application, semiocclusive, Closed Patch Test is conducted to measure the irritation potentialof cosmetic products on the skin.
Objective: To evaluatethe dermatological safety of investigational products by primary irritationpatch test on healthy human volunteers of varied skin types.
Duration of study: 8days study
**Kinetics:T0 (**Evaluation of test sites by Dermatand Subject,
Patchapplication)**,**T onevaporation of products, T+30mins post patch application, T1(Patch removal, Evaluation of test sites by Dermat andSubject post 30 minutes of patch removal), T2(Evaluationof test sitesby Dermat and Subject post 24 hrs of patchremoval),T8 (Evaluation of test sitesby Dermat and Subject post 1 week ofpatch removal and tracking the positive cases)
Population 24 healthysubjects(12 males + 12 females) The subjects are selected on the
basis of skin types:
3 males + 3 females fordry skin
3 males + 3 females foroily skin
3 males + 3 females forcombination skin
3 males + 3 females fornormal skin
Products : Perfume Spray (4170 A),Perfume Spray (4171 B), Soap (TSP 113-25B), Soap (TSP 113-24B), Soap (TSP113-38A), Soap (TSP 113-40A), Soap (TSP 113- 70), Soap (TSP 113- 71), Soap (TSP113- 44), Soap (TSP 112- 79), Soap (TSP 112 – 102), Soap (TSP 112 – 113), Soap(TSP 112- 121), Soap (TSP 112- 74), Face Wash (L6125), Face Wash (FW5970), SkinLeave-On (AAD- Trial 1), Skin Leave- On (AAN#Trial1), Skin Leave- On(WBS#115/01), Skin Leave-On (HFG#116004).
Positive control: 3% SLS
The test area is checkedfor erythema and oedema caused due to the products and
compared withpositive 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
- •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
dermatological safety of
时间窗: Baseline, 1day, 2 days and 8day
investigational products
时间窗: Baseline, 1day, 2 days and 8day
次要结局
- not applicable(not applicable)