CTRI/2024/02/062978招募中不适用
A clinical study to evaluate the safety and efficacy of Plum serum in Hair Growth and hairfall with Phototrichogram.
Pureplay Skin Sciences India Pvt Ltd1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年2月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Hair growth
研究概览
简要总结
Single arm clinical study to evaluate the safety and efficacy of plum serum in Hair Growth and hairfall. 1. Plum Hair Growth Serum
The products will be tested for skin irritation on 24 human volunteers.
Assessment would Notice improvement in Hairline / Bald patches with followup visit on T0min, T+2 days, T+28 days ,T+30 days, T+56 days T+58 days, T+84 days and T+86 days
Study is done as per BIS standard 4011
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian or Asian female and male subjects with max Female : Male Ratio – 80:20 with Stage 2 and 3
- •Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptomin the process of an exploratory checkup)
- •Between 25 and 40 years of age.
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
排除标准
- •â€¢ Being pregnant or breastfeeding or having stopped to breastfeed in the past three months • Having refused to give her assent by not signing the consent form • Taking part in another study liable to interfere with this study • Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area • Being insulin-dependent diabetic or non insulindependent diabetic with a recent therapy (less than 6 months) • Having a progressive asthma (either under treatment or last fit in the last 2 years) • Being epileptic • Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6months) • Having cutaneous hypersensitivity • Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products • Following a chronic or intermittent medicinal treatment comprising any of the following products : aspirin-based products, antiinflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) • Having undergone a surgery requiring a general anaesthetic of more than one hour in the past6 months • Having changed her cosmetic habits except those required by the protocol in the 14 dayspreceding the start of the study on the studied anatomic unit • Having applied a cosmetic product on the studied areas the first day of the study (except theusual shampoo).
结局指标
主要结局
Change in Hair growth
时间窗: T0min, T+2 days, T+28 days ,T+30 days, T+56 days T+58 | days, T+84 days and T+86 days
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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