To evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers with sensitive skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ITC LIMITED
- 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, Closed & Occlusive Patch Test is conducted to measure the irritation potential of cosmetic products on the skin.
Objective: To evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers with sensitive skin.
Duration of study: 8 days study Kinetics: T0 (Evaluation of test sites by Dermat and Subject, Patch application), T on patch Application Day, T+30mins post patch application, T1(Patch removal, Evaluation of test sites by Dermat), T2(Evaluation of test sites by Dermat and Subject post 24 hrs of patch removal), T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases)
Population 35 healthy subjects(17 males + 18 females)
The distribution of volunteers as per skin type will be as follows: Sensitive Combination skin : 4 Females + 4 Males Sensitive Dry skin – 4 Females + 4 Males Sensitive Oily skin – 5 Females + 5 Males Sensitive Normal skin – 4/5 Females + 4/5 Males
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Female and male Asian Indian subjects.
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 3)Subjects representing sensitive skin type (Subjects scoring greater than 30 for Section 2- Sensitive vs Resistant skin in Dr. Baumann’s questionnaire, please refer appendix 4) and varied skin type (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination).
- •For females: Urine pregnancy test (UPT) need to done.
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.
- •Having eczema, psoriasis, lichen planus, vitiligo etc.
- •in the concerned area.
- •Having healing disorder in the concerned area.
- •Having rhinitis, allergic conjunctivitis, or rhino sinusitis.
- •Having an allergy to perfumes and/or preservatives in cosmetic products.
- •Having an allergy to plaster / adhesives used in plaster.
- •Having a food allergy.
- •Having a cardiovascular pathology that requires beta blocking treatments.
- •Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
- •Taking specific treatment on the back.
- •Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study.
- •Having miliaria (prickly heat) on the back.
- •Presenting too many neavi on the back.
- •Having high pilosity on the back.
结局指标
主要结局
Dermatological safety / Irritation potential on skin
时间窗: Baseline,0 hrs,24 hrs & 7 days
次要结局
未报告次要终点
研究者
Dr Raji Patil
MASCOT-SPINCONTROL India Pvt. Ltd.