CTRI/2024/03/064647尚未招募不适用
To evaluate the in-vivo efficacy and safety of hair care formulation in terms of reduction in hair fall effect on human subjects
BEAUTY GARAGE INDIA PVT. LTD.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年3月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction in hair fall, Safety
研究概览
简要总结
Objective: The objective of this study is to evaluate the in-vivo efficacy and safety of hair care formulation in terms of reduction in hair fall effect on human subjects.
Population:36 (18 Females and 18 Males) subjects will be selected for the study.
The subjects selected for this study will be healthy male and females aged between 18 and 35 years,
having oily scalp and moderate to severe hair fall..
Study timepoints: Baseline, T+14 Days, T+28 Days
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Counting of fallen hair after standardized combing, Sebumetry
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Asian Indian humans subjects.
- •2.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 symptom in the process of an exploratory checkup) 3.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4.Having oily scalp and moderate to severe hair fall.
排除标准
- •1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •2.Having refused to give his/her assent by not signing the consent form.
- •3.Taking part in another study liable to interfere with this study.
- •5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6.Having a progressive asthma (either under treatment or last fit in the last 2 years) 7.Being epileptic 8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9.Having cutaneous hypersensitivity 10.Following a chronic or intermittent medicinal treatment comprising any of the following products : aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 11.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 12.Having changed her cosmetic habits except those mentioned in protocol in the 7 days preceding the start of the study on the studied anatomic unit.
结局指标
主要结局
Reduction in hair fall, Safety
时间窗: Baseline, 14 days, 28 days
次要结局
未报告次要终点
研究者
Dr Raji Patil
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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