A pilot study to evaluate the safety and efficacy of serums in improving hair growth in female subjects
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To evaluate and compare hair growth, thickness, reduction in hair fall after use of the test products in comparison to baseline and all time points by dermatological and instrumental assessments.
研究概览
简要总结
The screening phase comprises two visits, D-16 and D-14, where 45 eligible female subjects undergo informed consent, dermatological examination, and TrichoScan® assessment. Subjects discontinue other hair care medications before Visit 1 and return for TrichoScan® at Visit 2. On Day 1 of the treatment phase, subjects are randomized into three groups and receive test products (HS-1, HS-2, or HS-3). Baseline assessments are conducted, followed by subsequent visits for various assessments, including phototrichogram and Sebufix on Visioscan Camera on Day 3. Follow-up assessments occur at intervals of 30, 60, and 90 days, with subject self-assessment at specified visits and retrieval of test products and diaries at Day 62.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- Female
入选标准
- •1.Subjects complaining of hair fall and damage. 2.Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol. 3.Hair density of less than 100 and more than 200 hair follicle per square cm as per TrichoScan measurement 4.Female Subjects falling under Grade
- •Grade 6 of hair loss severity grade evaluated as per MSCR photo numerical 10-point 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
To evaluate and compare hair growth, thickness, reduction in hair fall after use of the test products in comparison to baseline and all time points by dermatological and instrumental assessments.
时间窗: Baseline, Week 2, Week 4, Week 8, Week 12
次要结局
- NA(NA)
研究者
Dr Mukesh Ramnane
M S Clinical Research