To evaluate the in-vivo safety and efficacy of Hair care formulation in terms of reduction in hair fall and reduction in dandruff 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
- Reduction in hair fall and reduction in dandruff
研究概览
简要总结
OBJECTIVE: The objective of this study will be to evaluate the in-vivo safety and efficacy of Hair care formulation in terms of reduction in hair fall and reduction in dandruff on healthy human subjects
The evaluation will be performed using: Subject’s Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Counting of fallen hair after standardized combing, Photographs of Scalp build-up by Denolite
The study lasts 42 days including the 14 days conditioning phase and 28 days treatment phase.
POPULATION: 36 (18 male & 18 female) subjects will be selected for the study.
The subjects selected for this study will be healthy human subjects, aged between 18 and 35 years, having moderate to severe hair fall and dandruff
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
- •1.Asian Indian male & female subjects.
- •2.Healthy subjects 3.Skin is healthy on the studied anatomic unit.
- •4.Having moderate to severe hair fall and dandruff.
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
Reduction in hair fall and reduction in dandruff
时间窗: Baseline, 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.