A clinical study to evaluate the efficacy of GroZen haircare liquid in promoting hair growth & protection in adult subjects over 24 weeks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of the test product in promoting hair growth and preventing hair thinning in comparison to baseline determined by dermatological and instrumental assessment.
研究概览
简要总结
This is a comparative hair growth efficacy study aims to evaluate the effectiveness of test products in promoting hair growth and reducing hair loss in adult male and female participants, comparing the results to baseline at specific time points. At Visit 1, subjects will undergo screening based on inclusion/exclusion criteria and provide informed consent before an initial dermatological evaluation. Following this, a washout period will take place. During the next visit, baseline assessments will be performed after acclimatization, focusing on hair thinning, quality, and density. Subjects will use the test product at home, with their compliance, adverse events, and progress monitored through subject diaries. Assessments will follow the same pattern for all 10 visits. The study duration is approximately 24 weeks for each subject, excluding the screening and washout periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects experiencing hair damage.
- •2.Subjects complaining of hair thinning and hair fall.
- •3.Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
排除标准
- •1.Subjects who have undergone any kind of hair growth treatment in the last 1 months (self-declared).
- •2.Subjects who have undergone hair transplant.
- •3.A known history or present condition of allergic response/hypersensitivity to any topical or oral cosmetic, pharmaceutical or nutraceutical product.
- •Subjects on oral medications like topical or systemic corticosteroids, undergoing any chemical hair salon treatment-straightening / perming / colour/ henna for past 2 to 3 months which will compromise the study.
- •5.Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness(self-declared).
结局指标
主要结局
To evaluate the effectiveness of the test product in promoting hair growth and preventing hair thinning in comparison to baseline determined by dermatological and instrumental assessment.
时间窗: Day-16, Day-14, Day 0, Day 2, Day 56, Day 58, Day 112, Day 114, Day 168, Day 170
次要结局
- To evaluate the overall safety of the test products(Day 0, Day 2, Day 56, Day 58, Day 112, Day 114, Day 168, Day 170)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd