Evaluation of irritation potential of Skin care formulation on healthy human subjects having varied skin type
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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 cosmetic products on the skin.
Objective: To evaluate the irritation potential on healthy human subjects of Skin Care Formulation.
Duration of study: 8 days study
Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application)
T1(Patch removal, Evaluation of test sites by Dermatologist
T2(Evaluation of test sites by Dermatologist 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: 24 healthy subjects (12 males + 12 females) with varied skin types.
The distribution of volunteers as per skin type will be as follows: Oily skin – 3 Females + 3 Males, Normal skin – 3 Females + 3 Males, Dry skin – 3 Females + 3 Males, Combination skin – 3 Females + 3 Males
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
- •Subjects willing to come for regular follow up and ready to follow instructions during the study period.
- •Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination).
排除标准
- •1For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2Having refused to give his/her assent by not signing the consent form 3Taking part in another study liable to interfere with this study 4Being diabetic. 5Being asthmatic. 6Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). 7Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin). 8Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 9Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months. 10Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 11The day of the patch application: no cosmetic product must be used (test site clean with water only). Refusing to follow the restrictions below during the study:.
- •For female: Do not become pregnant nor breastfeed.
- •Do not take part in another study liable to interfere with this study.
- •Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, and antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •Do not change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit 12Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area 13Having disorder of the healing (whatever the considered area) • Having a rhinitis, allergic conjunctivitis, or rhino sinusitis 14Having an allergy to perfumes and/or conservatives in cosmetic products 15Having an allergy to plaster 16Having a food allergy 17Having a cardiovascular pathology (taking a beta blocker treatment) 18Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc. 19Taking a retinoid-based treatment by general or oral route 20Taking specific treatment on the back. 21Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study 22Having miliaria (prickly heat) on the back. 23Presenting too many naevus on the back 24Having high pilosity on the back. 25Refusing to follow the restrictions below during the study:.
- •During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back.
- •Till the follow up period of until T8 days, only water is accepted from the first reading i.e., T2 days (24 hours after the patch removal).
- •Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches).
- •Do not expose the back to the sun.
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