The objective of this study will be to evaluate the sensitization potential of Skin Care formulations on healthy human subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- sensitization potential
研究概览
简要总结
The objective of this study is to evaluate the sensitization potential of Skin Care formulation on healthy human subjects
Product : TRAHNNA HEART-LEAVED MOONSEED PROTECTIONIST BODY SOOTHER(T-0123): Product A & TURMERISA DOUBLE TURMERIC FACIAL ESSENCE(T-0123): Product B
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 Plhase
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
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Female and male Asian Indian subjects.
- •2 Healthy Human subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup).
- •3 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4 Photo type III to V.
- •5 Having apparently healthy skin on Test area.
- •6 For whom the Investigator considers that the compliance will be correct.
- •7 Cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.
- •8 Having signed a consent form.
- •9 Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •10 Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise sauna…) during the course of the study.
- •11 Should be able to read and write in English Hindi or local language.
- •12 Having valid proof of identity and age.
排除标准
- •1 For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 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 Being diabetic. 5 Being asthmatic. 6 Following 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). 7 Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin). 8 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 9 Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months. 10 Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 11 The day of the patch application: no cosmetic product must be used (test site clean with water only). 12 Scars excessive terminal hair or tattoo on the studied area. 13 Henna tattoo anywhere on the body (in case of studies involving hair dyes). 14 Dermatological infection pathology on the level of studied area. 15 Hypersensitivity allergy antioxidant to any cosmetic product raw material or hair dye. 16 Any clinical significant systematic or cutaneous disease which may interfere with the study treatment or procedure. 17 Chronic illness which may influence the outcome of this study. 18 Subjects on any medical treatment either systematic or topical which may interfere with the performance of the study treatment presently or in the past one month. 19 Subject in an exclusion. Or participating in another food cosmetic or therapeutic trial. 20 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, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). , Do not change his/her cosmetic habit so yeah s apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
结局指标
主要结局
sensitization potential
时间窗: T2days, T4days, T6days, T9days, T11day, T13days, T16days, T18days, T20days. T25days
次要结局
未报告次要终点