Evaluation and comparison of in-vivo safety and efficacy of two hair care formulations in terms of Anti-dandruff effect.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Satiya nutraceuticals private limited
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- anti-dandruff effect
概览
简要总结
Primary Objective
The objective of this study will be to evaluate & compare the in-vivo safety and efficacy of two hair care formulation in terms of anti-dandruff effect on healthy human subjects:
Secondary Objective
The secondary objective of the study will be to evaluate the safety and efficacy of two hair care formulation in terms of moisturization & sebum reduction on healthy human subjects
The evaluation will be performed using: Subject’s Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Corneometry, Sebumetry, Photographs of scalp build-up by Denolite
The study will last for 35 days including the 7 days conditioning phase and 28 days application period.
POPULATION: 72 (36 male & 36 female) subjects will be selected for the study. The subjects selected for this study will be healthy male / female aged between 18 and 35 years, having moderate to severe dandruff.
36 subject for Test regime & 36 Subjects for comparative product) subjects
The study will be conducted in 2 groups.
Group A: This group will include 36 (18 male & 18 female) subjects using Regime (Product A to
Product D).
Group B: This group will include 36 (18 male & 18 female) subjects using comparative product E.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 male/female subjects.
- •2.Healthy subjects 3.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar.) 4.Having moderate to severe dandruff.
排除标准
- •for female, Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give her/his assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Being epileptic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
- •Having cutaneous hypersensitivity.
结局指标
主要结局
anti-dandruff effect
时间窗: Baseline, 2 days, 72 hours, Day 14, Day28
次要结局
- moisturization & sebum reduction(Baseline, 2 days, 72 hours, Day 14, Day28)
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.