A double blinded, randomized, placebo controlled study to evaluate the efficacy of hair tonic on healthy human subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- evaluate the safety and efficacy of the investigational product in hair fall control or growth in comparison to baseline and placebo
研究概览
简要总结
· In the study conducted with 100enrolled subjects, over a period of 108 days to evaluate the efficacy of hairtonic on healthy human subjects. By imaging assessment, the improvement was seen highest in group A comparedto group B.The products emerged to beoverall safe with no clinically significant site application reaction reported during the study .Both group-Aand group-B showed Improvement in flaking, itching and oiliness at visit11compared to baseline. Scalling improved in two subjects out of four subjectsreported at baseline. The severities of the dryness in one subject was resolvedat visit 11. Subjectperception on different parameters of hair was collected and assessed to be infavour of the both groups in hair fall rate and significant improvement in hair volume, hair growth rate andstrength of the hair at visit 11. The group A showed significantimprovement in reduction of hair fall on visit11 compared to group B by comb test (Hair with bulb) and the significantimprovement was observed in the reduction of hair fall in both group A andgroup B by comb test (Hair without bulb). Phototrichogram assessment: There was an improvement was observed in hair growthrate at visit9vsvisit8 in both group Aand Group-B at visit11 compared to visit 3 vs visit 2.
ReRESULTS: The improvement in hair densitywas found to be higher in Group A compared to Group B. Both the groups also effectivein scalp condition. Group A showed 100% normal scalp condition and group B showed 96.3% normal scalpcondition at visit 11.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Female subjects falling under Grade 2 – Grade-4 of hair loss severity grade 2)Male subjects falling under Grade 2 to Grade 4 of hair loss severity grade.
排除标准
- •Subjects who are undergoing hair growth treatment 3 months before screening into the study.
- •Subjects who have scalp conditions such as folliculitis, seborrheoic psoriasis of scalp, seborrheoic dermatitis and lichen planopilaris at the time of screening.
结局指标
主要结局
evaluate the safety and efficacy of the investigational product in hair fall control or growth in comparison to baseline and placebo
时间窗: 1)Dermatological assessment of hair and scalp will be done on visits 1, 2, 4, 6, 8, 10, 12 and visit 14.
次要结局
未报告次要终点