To evaluate invivo safety and efficacy of a Hair care formulation in terms of reduction in dandruff after one wash on healthy human subject
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction in dandruff after one wash
研究概览
简要总结
OBJECTIVE :The objectiveof this study will be to evaluate invivo safety and efficacy of a Hair careregime in terms of reduction in dandruff after two washes on healthy humansubject.
The evaluation is performed using:Subject’s Self Evaluation,Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation:Efficacy
The study lasts 7 days including the 2 daysconditioning phase and 5 days treatment period.
POPULATION : 36 subjects (18male & 18 female) are selected for the study.
The subjects selected for thisstudy are healthy male & female subjects aged between 18 and 35 years old,having mild to moderate dandruff
Test Products: Regime with Anti Dandruff Lotionand Anti Dandruff Shampoo
Anti Dandruff lotion will be applied once at nighton day 1 (T0) and day 4(T+3 days).
Anti dandruff shampoo will be used once in a day onwhole scalp on day 2(T+1 day) and day 5(T+4 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1Indian / Asian male and female subjects.
- •2Healthy 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) 3Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4Having mild to moderate dandruff.
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 is liable to interfere with this study.
- •4Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6Having a progressive asthma (either under treatment or last fit in the last 2 years) 7Being epileptic 8Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9Having cutaneous hypersensitivity 10Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products 11Following a chronic or intermittent medicinal treatment comprising any of the following products :aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 12Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 13Having changed his/her cosmetic habits except those required by the protocol in the 3 days preceding the start of the study on the studied anatomic unit 14Having applied a hair care products and cosmetic products on the studied area the first day of the study (except hair washed with the provided neutral shampoo one day prior to the day of visit.) 15Having applied a hair care product on study visits including test products.
结局指标
主要结局
Reduction in dandruff after one wash
时间窗: Baseline, 24 hours after application, 48 hours after application
次要结局
未报告次要终点