An Open label, Clinical Safety and Efficacy Study for evaluation of Hair oil in reduction in hairfall, reduction in dandruff and hair growth in healthy adult subjects.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.Evaluate the efficacy of the product for reducing hair fall.
研究概览
简要总结
An Open label, Clinical Safety and Efficacy Study for evaluation ofHair oil in reduction in hair fall, reduction in dandruff and hair growtin healthy adult subjects.This is an open label, clinical study to evaluate efficacy and safety of hair oil in subjects with hairfall, dandruff, and hair loss.The potential subjects will be screened as per the inclusion and exclusion criteria only afterobtaining written informed consent from the subjects.Study visits will consist of a screening and enrollment visit, evaluation follow up visits at day atday 14 (± 1 day), day30 (± 1 day), and day 60(± 1 day) end of study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with Hair loss problems,mild to moderate dandruff and thinning of hair.
- •Healthy Adult Volunteers of ≥18 to ≤ 50 years inclusive of both genders
- •Subjects generally in good health and willing to give written informed consent and willing to follow the study procedure will be enrolled in the study
- •Subjects with hair all count of 40-50 for females and 25-30 for males as evaluated by 60secs comb test .
排除标准
- •1.History of any dermatological conditions of the scalp (other than dandruff or seborrheic dermatitis or hair loss) that would interfere with the diagnosis or assessment (e.g. psoriasis, eczema, atopic dermatitis, or other skin/scalp infections).
- •Subjects with excessive erythema, crusting or a significant number of pustules/papules on the scalp.
- •History ofskin cancer or treatment for any type of cancer within the last 2 years.
- •History of prior use of antidandruff treatment on scalp within past 1 month.
- •Participation in a similar clinical study within the previous 90 Days.
结局指标
主要结局
1.Evaluate the efficacy of the product for reducing hair fall.
时间窗: Baseline,Day 14,Day 30,Day 60
2. Safety of the product in the treatment of dandruff.
时间窗: Baseline,Day 14,Day 30,Day 60
3. Evaluating the efficacy and safety of product on increasing the hair growth or reducing the thinning of Hair
时间窗: Baseline,Day 14,Day 30,Day 60
次要结局
- NA(NA)