CTRI/2021/09/036928已完成不适用
To evaluate the Anti-dandruff efficacy of test products in healthy Indian human
Unilever Industries Pvt Ltd1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2021年4月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Significant improvement in dandruff condition by expert/dermatologist assessment
研究概览
简要总结
Study will be conducted to assess the efficacy of test product in imparting hair dandruff benefits. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. Post baseline assessments, test product will be dispensed to subjects as per randomization and subjects will be instructed to use the product thrice a week and evaluation assessments will be done at different times points over a period of 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 42.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Female and male subjects in the ratio of 2:1 in general good health.
- •2.Subjects in the age group 18-42 years (both the ages inclusive).
- •3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
- •4.Subjects willing to abide by and comply with the study protocol.
- •5.Subjects who have not participated in a similar investigation in the past three months.
- •6.Subjects who agree to refrain from using hair dye / hair colour /henna during the study period.
- •7.Subjects willing to refrain from any type of hair treatment like perming, straightening etc.
- •during the study duration 8.Subjects who agree not to change their regular regimen (including hair oils).
排除标准
- •1.Subjects who have undergone hair growth treatment within 3 months before screening into the study.
- •2.Subjects having any active scalp disease which may interfere in the study – dermatologist’s judgement.
- •3.Subjects (male) having androgenic alopecia, male pattern baldness’ not be included in study.
- •4.Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
- •5.Subjects (females) who are pregnant or lactating 6.Subjects who have had hair transplant.
- •7.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •8.Chronic illness which may influence the cutaneous state.
- •9.Subjects participating in other similar cosmetic or therapeutic trial within last three months 10.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
- •11.Subjects (males) who are having androgenic alopecia, male pattern baldness.
结局指标
主要结局
Significant improvement in dandruff condition by expert/dermatologist assessment
时间窗: 4 weeks product and 2 weeks regression
次要结局
- Significant reduction and prevention of dandruff associated conditions by expert/dermatologist assessment(4 weeks product and 2 weeks regression)
研究者
研究点 (1)
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