To evaluate the in vivo efficacy and safety of a hair care formulation in terms of hair growth i.e. improvement in AT ratio 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
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 a hair care formulation in terms of hair growth i.e. improvement in AT ratio and reduction in hair fall on healthy human subjects.
The evaluation is performed using: Subject’s Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Phototrichogram Analysis, Counting of Fallen Hair after Standardized Combing, Analysis of hair thickness through Dino-lite Digital Microscope, Hair pull test, Macro photographs of the Scalp & Hair Shaft.
POPULATION :36 (18 male and 18 female) subjects will be selected for the study. The subjects selected for this study will be healthy males & females aged between 30 and 50 years & showing initial stage of baldness, For Males: Norwood Hamilton Scale Class II to III (including III, IIIA and III vertex); for Females: Ludwig and Savin 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
- •Indian or Asian male & female subjects.
- •Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3)Between 30 and 50 years of age.
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 5)Having androgenetic alopecia of class I-2 to I-4 according to Ludwig and Savin 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
- •For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2)Having refused to give his/her assent by not signing the consent form Taking part in another study liable to interfere with this study 3)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 4)Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5)Having a progressive asthma (either under treatment or last fit in the last 2 years) 6)Being epileptic 7)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8)Having cutaneous hypersensitivity 9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products 10)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) 11)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 12)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 13)Having applied a cosmetic product on the studied areas the first day of the study.
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.