To evaluate the safety and efficacy of the test products in comparison to baseline in improving hair growth rate and reducing hair fall among healthy subjects
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- • Reduction in hair fall by comb test
研究概览
简要总结
The study is designed to investigate the effectiveness and safety of a new product related to hair growth. It will be conducted in a single location, with a double-blinded, randomized approach. The study will last for 12 weeks, involving 10 visits for participants. The first two visits focus on screening, randomization, and baseline assessments. Subsequent visits include shaving and assessment, along with follow-up assessments at different time points. Participants will be divided into three test groups, and after the initial 4 weeks, only two of these groups will continue with the study. Various assessments, including TrichoScan® (a method for hair assessment), will be conducted throughout the study. Participants will be instructed to discontinue any other hair care medications during the study, and they will receive the assigned test product along with a neutral shampoo. Regular follow-up visits will assess the participants’ progress, and those who discontinue the study will sign an exit form. The study aims to gather information on the effects of the test product on hair growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects in general good health.
- •Subjects in the age group 18-50 years (both the ages inclusive).
- •Subjects complaining of hair fall and damage.
- •Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
- •Hair density of greater than 100 and less than 200 hair follicle per square cm as per TrichoScan measurement
- •Male and female Subjects falling under Grade
- •Grade 6 of hair loss severity grade evaluated as per MSCR photo numerical 10-point scale (Linear scale for assessment purpose-In Use Scale).
排除标准
- •1 Subjects who have undergone any kind of hair growth treatment in the last 3 months 2 Subjects having any active but controllable scalp disease which may interfere in the study assessments 3 Subjects who have taken chemotherapy for cancer in the 6 months prior to the studys start 4 Subjects who have history of crash dieting and or psychiatric disorder including trichotillomania 5 Subjects who have undergone hair transplant 6 A known history or present condition of allergic response or hypersensitivity to any topical or oral cosmetic pharmaceutical or nutraceutical product 7 Subjects on oral medications like topical or systemic corticosteroids undergoing any chemical hair salon treatment which will compromise the study 8 Subjects with chronic illness which may influence the cutaneous state 9 Subjects who are pregnant or nursing Self declared 10 Subjects with any history or present of underlying uncontrolled medical illness or any other serious medical illness.
结局指标
主要结局
• Reduction in hair fall by comb test
时间窗: at Baseline, Week 2, Week 4, Week 8, Week 12
• Improvement in hair growth rate, hair thickness, hair density by TrichoScan and dermatological assessments
时间窗: at Baseline, Week 2, Week 4, Week 8, Week 12
• Change in anagen and telogen ratio by TrichoScan
时间窗: at Baseline, Week 2, Week 4, Week 8, Week 12
次要结局
- • Change in hair thinning by dermatologists(• Overall safety of test product)
研究者
Dr Mukesh Ramnane
MS Clinical Research