Evaluation of the sensitization potential of Skin Care Formulation on healthy human subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 1
研究概览
简要总结
The objective of this study will be to evaluate the sensitization potential of skin care formulation on healthy human subjects
The evaluation is performed using: Dermatological Evaluation: Human Repeat Insult Patch Test Method
Total duration of the study: 40 days following the first application of product.
Kinetics: Induction phase with 21 visits( T0, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12, T13, T14, T15, T16, T17, T18, T19 and T20) then resting phase of 14 days and 5 days of Challenge phase( T21, T22, T23, T24 & T25)
**The study is conducted in 3 phases: 1.****Induction Phase, 2.****Resting Phase,3.**Challenge Phase
Induction phase is of 21 days and in which 9 repeated applications of patches are carried out which are removed after 24 hours of application and evaluated after 24 hours of patch removal. Resting phase is of 14 days in which no application of any patch is done in order to develop sensitization to the test product. In Challenge phase only one patch is applied which is removed after 24 hours and evaluated after 24 hours 48 hours and 72 hours
Number of volunteers: 220 (110 male+110 female) subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
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 3)Having Photo type III to V.
排除标准
- •For female: Pregnant/nursing mothers 2)Having refused to give his/her assent by not signing the consent form 3)Taking part in another study liable to interfere with this study 4)Having participated in study in past one month.
- •Being diabetic.
- •Being asthmatic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol).
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
- •Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
- •Having Scars, excessive terminal hair or tattoo on the studied area.
- •Having Henna tattoo anywhere on the body (in case of studies involving hair dyes).
- •Having Dermatological infection/pathology on the level of studied area.
- •Having Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
- •Having any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •Having chronic illness which may influence the outcome of the study.
- •Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.