To evaluate the in-vivo safety and efficacy of Hair care formulation in terms of reduction in hair fall and improvement in hair growth (Hair Length) on healthy female 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 improvement in hair growth (Hair Length)
研究概览
简要总结
OBJECTIVE- The objective of this study will be to evaluate the in-vivo safety andefficacy of Hair care formulation in terms of reduction in hair fall andimprovement in hair growth (Hair Length) on healthy female subjects forproducts
POPULATION- 36 Female subjects will be selected for the study. The subjects selected forthis study are healthy females, aged between 40 and 55 years old havingmoderate to severe hair fall,
DURATION- 56 days including the 28 days of conditioning phase and 28 days of treatmentphase(For hair growth results obtained in treatment phase will be compared withthat of natural growth in conditioning phase)
STUDYDESIGN - Single blind study.
Theevaluation is performed using- 1)Dermatological Evaluation: Safety 2)Measurementof Hair Growth by Bleaching Technique 3)Counting of Fallen Hair afterStandardized Combing 4)Subject self evaluation
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
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian female subjects.
- •Healthy subjects 3)Skin & scalp is healthy on the studied anatomic unit 4) Having moderate to severe hair fall.
排除标准
- •Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 2) Having a progressive asthma (either under treatment or last fit in the last 2 years) 3) Being epileptic 4) Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 5) Having cutaneous hypersensitivity 6) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products 7) Following 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) 8) Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 9) Having changed his/her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
- •Having applied a hair care product and cosmetic product on the studied area as well as on the face the first day of the study (except the neutral shampoo without anti hairfall claim or hair growth claim) 11)Having naturally fair or white hair (Which will interfere the evaluation) 12)Having a dermatosis on the scalp 13)Having surgery history on the scalp (micro transplants) 14)Refusing the bleaching of two areas of the scalp of approx.
- •40 hairs, the first day of the study.
- •Refusing the pluking of approx.
- •10 hairs, during the entire study 16)Having presented a factor inducing a telogen effluvium in the 3 months preceding the start of the study (delivery, important stress, high fever).
结局指标
主要结局
Reduction in hair fall and improvement in hair growth (Hair Length)
时间窗: Baseline, 28 days
次要结局
未报告次要终点