To evaluate the in-vivo safety and efficacy of a hair care formulation in terms of hair growth i.e. improvement in AT ratio 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 growth i.e. improvement in A:T ratio
研究概览
简要总结
The objective of this study will be to evaluate the in-vivo safety and efficacy of a hair care formulation in terms of hair growth i.e. improvement in A:T ratio on healthy human subjects.
The evaluation will be performed using: Subject’s self assessment questionnaire, Dermatological evaluation: Cosmetic Acceptability, Phototrichogram Analysis, Macro photographs of the Scalp & Hair Shaft
The study lasts 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 30 and 50 years & showing initial stage of baldness, For Males: Hamilton Scale Class II to III (including III, IIIA and IIIvertex); for Females: Ludwig Scale I-2 to I-4).
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
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian / Asian male & female subjects.
- •Healthy subjects
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
- •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 IIIvertex) 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
- •Having refused to give his/her assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
- •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 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) 12.
结局指标
主要结局
Improvement in hair growth i.e. improvement in A:T ratio
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 India Pvt. Ltd.