A Randomized, Placebo-Controlled, Parallel-Group Comparative Clinical Study to Evaluate the Efficacy and Safety of a Hair Serum Alone and in Combination with Gummies, Compared to Placebo, in Reducing Hair Fall and Promoting Hair Growth in Male and Female Participants.
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- 1. To evaluate and compare hair growth from baseline
研究概览
简要总结
This study will enroll 105 male and female participants (7:3 ratio) who meet the eligibility criteria and provide informed consent. The study is designed to compare the test products with placebo, as well as evaluate differences within the treatment groups, At screening (Visit 1, Day –16), participants will undergo health screening, medical history, and dermatological evaluation, followed by a Trichoscan at Visit 2 (Day –14) before a two-week washout period, during which they will stop all hair growth products and use a neutral shampoo.
Baseline assessments at Week 0 (Visit 3, Day 0) will include imaging, dermatological and instrumental tests, hair comb test, Trichoscan, and self-assessment. At Visit 4 (Day 2), participants will undergo Trichoscan, be randomized into three groups, receive the study product, and start daily diary recording.
Follow-up visits at Weeks 4, 8, and 12 will repeat baseline assessments. The final visit will include product and diary collection and study exit procedures. Site application reactions, concomitant medications, and any adverse events will be monitored throughout.
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 40.00 Year(s)(—)
- 性别
- All
入选标准
- •Trial participants in the age group 18-40 years.
- •Female and male trial participants in the ratio 7:3 in all three groups.
- •Trial participants willing to undergo shaving of a test area on the scalp and have a mark in the target area.
- •Trial participants able to read, understand, and provide informed consent.
- •Trial participants willing to give a written informed consent and willing to abide by and comply with the study protocol.
排除标准
- •Trial participants who have undergone any kind of hair growth treatment in the last 3 months
- •Trial participants having any active scalp disease which may interfere with the study
- •Prior use of scalp hair growth treatment within 6 months.
- •Trial participants who have taken chemotherapy for cancer in the 6 months prior to the study start.
- •Trial participants who have undergone hair transplant.
结局指标
主要结局
1. To evaluate and compare hair growth from baseline
时间窗: Week 0, Week 4, Week 8, Week 12
at all subsequent time points in trial participants receiving Hair Serum alone, Hair Serum combined with Hair Vitamin Gummies, and Placebo, as measured by TrichoScan.
时间窗: Week 0, Week 4, Week 8, Week 12
2. To evaluate and compare hair density from baseline
时间窗: Week 0, Week 4, Week 8, Week 12
at all subsequent time points in participants receiving
时间窗: Week 0, Week 4, Week 8, Week 12
Hair Serum alone, Hair Serum combined with Hair Vitamin Gummies, and Placebo, as measured by TrichoScan.
时间窗: Week 0, Week 4, Week 8, Week 12
3. To evaluate and compare change in anagen to
时间窗: Week 0, Week 4, Week 8, Week 12
telogen ratio (A/T ratio) at day 86 in comparison to
时间窗: Week 0, Week 4, Week 8, Week 12
baseline as measured by TrichoScan
时间窗: Week 0, Week 4, Week 8, Week 12
次要结局
- 1. To evaluate hair fall by comb test in comparison to(baseline and all defined time points.)
研究者
Dr Suhail Khan M K
MS Clinical Research Pvt. Ltd
