To evaluate in vivo safety and efficacy of hair care formulation in terms of improvement in hair thickness and reduction in hair fall 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 hair thickness and reduction in hair fall
研究概览
简要总结
The objective of this study will be to evaluate in vivo safety and efficacy of hair care formulation in terms of improvement in hair thickness and reduction in hair fall on healthy human subjects.
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Corneometry, Analysis of hair thickness through Dino-lite Digital Microscope and Counting of Fallen Hair after Standardized Combing.
The study last 84 days following the first application of the product.
POPULATION: 36 (18 male and 18 female) subjects will be selected for the study.
The subjects selected for this study are healthy males & females aged between 18 and 35 years having mild to moderate hair fall & dull and dry hair with split ends
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 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian female subjects
- •Healthy subjects
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
- •Having mild to moderate hair fall
- •Having dull and dry hair with split ends.
排除标准
- •For female: 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
- •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)
- •Being epileptic.
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Having cutaneous hypersensitivity
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •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) 11.
结局指标
主要结局
improvement in hair thickness and reduction in hair fall
时间窗: Baseline, Day 28, Day 56, Day 84
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
Mascot Spincontrol Pvt Ltd