To evaluate the in vivo safety and efficacy of hair care regime in terms of hair growth i.e., improvement in A is to T 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
研究概览
简要总结
Objective:The objective of this study will be to evaluate in-vivo safety and efficacy of hair care regime in terms of hair growth i.e., improvement in A:T ratio on healthy human subjects for regime.
Kinetics: T0, T+28 days, T+56 days and T+84 days
Population: 36 healthy human subjects (18 males + 18 females).
The subjects selected for this study are healthy males and females aged between 30 and 50 years, showing initial stage of baldness, For Males: Hamilton Scale Class II to III (including III, IIIA and III vertex) ; for Females: Ludwig 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
- •Healthy male and female volunteers between 30-50 years of age.
- •Subjects showing initial stage of baldness, For Males: Hamilton Scale Class II to III (including III, IIIA and III vertex); for Females: Ludwig Scale I-2 to I-4).
排除标准
- •Volunteer pregnant or planning to become pregnant.
- •Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
- •Volunteers with any other signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
- •Volunteers having chronic illness or had major surgery in the last year.
结局指标
主要结局
Improvement in Hair Growth
时间窗: T0, T+28 days, T+56 days and T+84 days
次要结局
未报告次要终点
研究者
Dr Niharika Salian
Mascot Spincontrol India Pvt. Ltd.