To evaluate in vivo safety and efficacy of hair care formulation in terms of hair growth i.e., improvement in A is to T ratio, improvement in hair density, reduction in hair fall and improvement in hair strength 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
- 36
- 试验地点
- 1
- 主要终点
- Improvement in A:T ratio, improvement in hair density, reduction in hair fall and improvement in hair strength
研究概览
简要总结
OBJECTIVE : The objective of this study will be to evaluate in-vivo safety and efficacy of hair care formulation in terms of hair growth i.e., improvement in A:T ratio, improvement in hair density, reduction in hair fall and improvement in hair strengthon healthy human subjects The evaluation will be performed using: Subject’s self-assessment questionnaire, Dermatological evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Phototrichogram Analysis, Analysis of hair thickness through Dino-lite Digital Microscope, Counting of Fallen Hair after Standardized Combing
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 30 and 50 years & showing initial stage of baldness, For Males: Hamilton Scale Class II to III (including III, IIIA and III vertex) ; for Females: Ludwig Scale I-2 to I-4). STUDY DURATION : 84 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 and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Indian or Asian male & female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Having androgenetic alopecia of class I-2 to I-4 according to Ludwig Scale for females and class II to III (including III, IIIA and III vertex) according to Norwood Hamilton Scale for males.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give her/his assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Being epileptic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
- •Having cutaneous hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
结局指标
主要结局
Improvement in A:T ratio, improvement in hair density, reduction in hair fall and improvement in hair strength
时间窗: Baseline, 28 Days, 56 Days, 84Days
次要结局
未报告次要终点
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.