A prospective, open label clinical study to evaluate the efficacy and safety of Hair serum on Hair Growth and Hair Fall in healthy adult humans.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 5 Clinical photographs of the vertex and superior frontal scalp
研究概览
简要总结
A prospective, open label clinical study to evaluate the efficacy and safety of Hair serum in 40 healthy adult male and female volunteers. The individual subject participation will be for 90 days. The efficacy assessments for the study will be subject self assessment questionnaire, visual analog scale, 60 second hair comb test, hair pull test, clinical photographs, investigator assessment scale, hair analysis by Trichoscan. The secondary assessment for the study include safety outcomes like monitoring of adverse or serious adverse events and abnormal vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male and female healthy adult subjects ranging in age from 18 to 65 years both inclusive.
- •3 Agree not to use any medication, including vitamins and minerals during or before the course of this study.
- •4 Mild to moderate hair loss classified as the Norwood-Hamilton type II,III,IV and V in males and Ludwig type I and II in females.
- •5 Willing to come for all follow-up visits.
排除标准
- •1 Any clinically significant medical history, medical finding or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- •2 On any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to study commencement.
- •3 History of hypersensitivity reactions.
- •4 Participation in a clinical study during the preceding 90 days.
结局指标
主要结局
5 Clinical photographs of the vertex and superior frontal scalp
时间窗: 1 Subject Self Assessment(Screening,Day30,Day60 & Day90) | 2 VAS(Screening,Day30,Day60 & Day90) | 3 60 Second Hair Comb test(Screening,Day30,Day60 & Day90) | 4 Hair Pull Test(Screening,Day30,Day60 & Day90) | 5 Clinical photographs(Screening & Day90) | 6 Investigator Assessment Scale(Day90) | 7 Trichosan Analysis(Screening & Day90)
1 Subject Self Assessment Questionnaire
时间窗: 1 Subject Self Assessment(Screening,Day30,Day60 & Day90) | 2 VAS(Screening,Day30,Day60 & Day90) | 3 60 Second Hair Comb test(Screening,Day30,Day60 & Day90) | 4 Hair Pull Test(Screening,Day30,Day60 & Day90) | 5 Clinical photographs(Screening & Day90) | 6 Investigator Assessment Scale(Day90) | 7 Trichosan Analysis(Screening & Day90)
2 Visual Analog Scale
时间窗: 1 Subject Self Assessment(Screening,Day30,Day60 & Day90) | 2 VAS(Screening,Day30,Day60 & Day90) | 3 60 Second Hair Comb test(Screening,Day30,Day60 & Day90) | 4 Hair Pull Test(Screening,Day30,Day60 & Day90) | 5 Clinical photographs(Screening & Day90) | 6 Investigator Assessment Scale(Day90) | 7 Trichosan Analysis(Screening & Day90)
7 Hair Analysis by Trichoscan Hair density, hair diameter, hair growth rate, or anagen/telogen ratio
时间窗: 1 Subject Self Assessment(Screening,Day30,Day60 & Day90) | 2 VAS(Screening,Day30,Day60 & Day90) | 3 60 Second Hair Comb test(Screening,Day30,Day60 & Day90) | 4 Hair Pull Test(Screening,Day30,Day60 & Day90) | 5 Clinical photographs(Screening & Day90) | 6 Investigator Assessment Scale(Day90) | 7 Trichosan Analysis(Screening & Day90)
3 60 Second Hair Comb test
时间窗: 1 Subject Self Assessment(Screening,Day30,Day60 & Day90) | 2 VAS(Screening,Day30,Day60 & Day90) | 3 60 Second Hair Comb test(Screening,Day30,Day60 & Day90) | 4 Hair Pull Test(Screening,Day30,Day60 & Day90) | 5 Clinical photographs(Screening & Day90) | 6 Investigator Assessment Scale(Day90) | 7 Trichosan Analysis(Screening & Day90)
4 Hair Pull Test
时间窗: 1 Subject Self Assessment(Screening,Day30,Day60 & Day90) | 2 VAS(Screening,Day30,Day60 & Day90) | 3 60 Second Hair Comb test(Screening,Day30,Day60 & Day90) | 4 Hair Pull Test(Screening,Day30,Day60 & Day90) | 5 Clinical photographs(Screening & Day90) | 6 Investigator Assessment Scale(Day90) | 7 Trichosan Analysis(Screening & Day90)
6 Investigator Assessment Scale
时间窗: 1 Subject Self Assessment(Screening,Day30,Day60 & Day90) | 2 VAS(Screening,Day30,Day60 & Day90) | 3 60 Second Hair Comb test(Screening,Day30,Day60 & Day90) | 4 Hair Pull Test(Screening,Day30,Day60 & Day90) | 5 Clinical photographs(Screening & Day90) | 6 Investigator Assessment Scale(Day90) | 7 Trichosan Analysis(Screening & Day90)
次要结局
- 1 Adverse Events(1 Adverse Events (Visit 3, Visit 4, Visit 5 and via telephonic follow up to 15 days after Day 90).)