To evaluate the invivo efficacy and safety of hair care formulation in terms of hair growth ie improvement in AT ratio on healthy human subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Hair growth i.e. improvement in AT ratio
研究概览
简要总结
OBJECTIVE: The objective of this study will be to evaluate the in-vivo efficacy and safety of hair care formulation in terms of hair growth i.e. improvement in AT ratio on healthy human subjects
The evaluation is performed using:Subject’s self-assessment questionnaire, Dermatological evaluation: Cosmetic Acceptability, Phototrichogram Analysis, Macro photographs of the Scalp & Hair Shaft
The study lasts 28 days following the first application of the product.
POPULATION:36 (18 male and 18 female) subjects are selected for the study.
The subjects selected for this study are healthy males & females aged between 18 and 50 years old, having different conditions of alopecia, presenting hair thinning basis visual /dermatological assessment & having hair density between 100-150 per square centimeter.
STUDY DURATION: 28 days following the first application of the product
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male & female subjects in the age group of 18 to 45 years.
- •Subject is having valid proof of identity and age.
- •Subjects suffering from Alopecia.
- •Subjects with hair thinning based on visual /dermatological assessment.
- •Subjects having hair density between 100-150 per square centimeter.
排除标准
- •For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •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 a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6)Having a progressive asthma (either under treatment or last fit in the last 2 years) 7)Being epileptic 8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9)Having cutaneous hypersensitivity 10)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products 11)Following a chronic or intermittent medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 12)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
结局指标
主要结局
Hair growth i.e. improvement in AT ratio
时间窗: Baseline, Day 7, Day 14 and Day 28
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.