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 / 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 cosmeticproducts on the skin.
Objective: To evaluate the dermatological safety of investigational products by primaryirritation 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),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 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:**Skin Leave- On (BMEO01), Skin Leave – On (BMEO02), Skin Leave- On (GFEO01), Skin Leave - On (GFEO02), Skin Leave – On (LGEO01), Skin Leave – On (LGEO02),Skin Leave – On (LGEO03),Skin Leave – On (LGEO04),Skin Leave – On (PMEO01),Skin Leave – On (PMEO02),
Positive control: 3% SLS
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 representationof all 4 skin types – Oily, Normal, Dry and combination)Subjects willing to come for regular follow up and ready to followinstructions during the study period.
排除标准
- •For female : Being pregnant or breastfeeding or having stopped tobreastfeed in the past three months, Having refused to give his/herassent by signing the consent form,Taking part in another studyliable to interfere with this studyBeing diabetic,Beingasthmatic,Having eczema, oriasis, lichen plan,vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergicconjunctivitis or rhinosinusitis.
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
- not applicable(not applicable)