CTRI/2025/02/079940尚未招募2 期
A clinical study to evaluate the Anti dandruff efficacy of test product.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Significant reduction in dandruff flakes
研究概览
简要总结
This clinical trial is being conducted to ascertain the efficacy and safety of test product on healthy human Indian volunteers suffering from dandruff.
Volunteers will be enrolled basis on inclusion criteria mentioned in the protocol.
Product usage instruction will be provided to volunteers at the initiation of the study. Safety and efficacy assessment will be done by the dermatologist and ayurvedic doctors at regular period on weekly basis. Assessment will be compared change form baseline value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male & female volunteers between 18-45 years of age. 2)Volunteer presenting with dandruff as per dermat assessment 3)Volunteer in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data. 4)Volunteer able to read, understand and sign an appropriate informed consent form indicating her willingness to participate. 5)Volunteers agreeing to comply with following study restrictions:.
- •Volunteers Willing to refrain from application of any other product/treatment on their scalp and hair shafts during the study period.
- •Not applying any cosmetic, hair care product, test product and/or water 48 hours before scheduled visits.
排除标准
- •Volunteers who participated in a study with scalp/ hair shaft as the target area within 4 weeks of the start of this study or is currently participating in such a study.
- •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 with self-perceived sensitive skin.
- •Volunteers having chronic illness or had major surgery in the last year.
- •Volunteers undergoing any treatment of any skin condition on body.
结局指标
主要结局
Significant reduction in dandruff flakes
时间窗: Baseline, 1 week, 2 week, 3 weeks, 4 week and 5 weeks
次要结局
- Reduction in scalp itch(Baseline, 1 week, 2 week, 3 weeks, 4 week and 5 weeks)
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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