CTRI/2022/02/040653尚未招募不适用
To evaluate the in-vivo efficacy and safety of a hair care formulation in terms of reduction in Hair Fall and Anti-dandruff effect on healthy male & female subjects
Kama Ayurveda Pvt Ltd1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年3月3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, Reduction in Anti-dandruff effect
研究概览
简要总结
Objective: The objective of this study will be to evaluate in-vivo safety and efficacy of hair care formulation in terms of reduction in Hair Fall and Anti-dandruff effect on healthy female & male subjects
Duration of study: 35 days study (The study lasts 35 days including the 7 days conditioning phase and 28 days application period)
Kinetics: Screening (T-7 days), T0, T+14 days and T+28 days
Population: 36 (18 Females & 18 Males) volunteers
The evaluation is performed using:
-
Subject’s Self Evaluation,
-
Dermatological Evaluation: Cosmetic Acceptability,
-
Dermatological Evaluation: Efficacy
-
Counting of fallen hair after standardized combing
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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
- •Having moderate to severe hair fall.
- •Having Moderate to severe dandruff (where 0 is None, 1 is Slight, 2 is Mild, 3 is Moderate, 4 is Severe)
- •Suffering with hair thinning on subject assessment basis.
- •For female: Having at least shoulder length hair.
- •Having washed their hair with provided neutral shampoo, 48 hours before the first day of the study with the provided nuetral shampoo.
- •Having untangled their hair at home, 3 hours prior coming to the site for observations, the first day of the study.
排除标准
- •Small, red bumps on the scalp, neck, and shoulders (bumps may become crusty and ooze).
- •Subject having applied a product with an anti-hair fall claim (due to breakage)or anti dandruff claim in the 2 weeks preceding the start of the study.
- •Having surgery history on the scalp (micro transplants …)
- •In the previous 6 months, Having undergone the Minoxidil treatments, Antiandrogen medicine (cyproterone acetate, spironolactone, flutamide), Having undergone one of the following treatments known to : induce hair loss : retinoids, anti coagulants, anti-convulsive drugs, chemotherapy, beta-blocking agents, non steroidal anti inflammatory drugs, corticoids,Having modified her hormonal contraception.
- •In the previous 3 months, Having undergone a local or general anti hair loss treatment (Biotine, dexpanthenol, sulphur amino-acid, B6 vitamin, zinc), Having taken a food supplement with an anti hair loss claim, Having taken an iron based treatment
- •In the previous 15 days, Having applied a product with an anti hair loss claim (due to breakage) or anti dandruff claim.
结局指标
主要结局
Reduction in Hair Fall, Reduction in Anti-dandruff effect
时间窗: T0, 14 days and 28 days
次要结局
- Safety on skin(T0, 14 days and 28 days)
研究者
研究点 (1)
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