CTRI/2025/09/094465尚未招募不适用
To evaluate the in-vivo safety and efficacy of hair care regime in terms of anti-dandruff effect on healthy human subjects
Qi Naturals1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年9月18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 Dandruff
研究概览
简要总结
Objective:The objective of this study will be to evaluate the in-vivo safety and efficacy of hair care regime in terms of anti-dandruff effect on healthy human subjects.
Kinetics: T-14 days, T0, T+14 days & T+28 days
Population: 36 healthy human subjects (18 males + 18 females).
The subjects selected for this study are healthy males and females aged between 18 and 35 years, having moderate to severe dandruff with an itchy scalp.
STUDY DURATION: 42 days including the 14 days conditioning phase and 28 days treatment phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor 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
- •Healthy male and female volunteers between 18-35 years of age.
- •Subjects having moderate to severe dandruff with an itchy scalp.
排除标准
- •Volunteer pregnant or planning to become pregnant.
- •Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
- •Volunteers with any other signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
- •Volunteers having chronic illness or had major surgery in the last year.
结局指标
主要结局
Reduction in Dandruff
时间窗: T-14 days, T0, T+14 days & T+28 days
次要结局
未报告次要终点
研究者
Dr Niharika Salian
Mascot Spincontrol India Pvt. Ltd.
研究点 (1)
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