To evaluate and compare the safety & efficacy of Skin care formulations in terms of Reduction in Acne and sebum reduction on healthy female subjects
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 Acne (live/occurring) and sebum reduction
研究概览
简要总结
OBJECTIVE: The objective of this study will be to evaluate and compare the safety & efficacy of Skin care formulations in terms of Reduction in Acne (live/occurring) and sebum reduction on healthy female subjects.
The evaluation is performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Sebumetry
The study will last 28 days be following the application of the product.
POPULATION: 36 subjects will be selected for the study. These subjects will be divided into 2 groups of 18 female subjects each.
Group A: This group will include 18 female subjects using test Product A
Group B: This group will include 18 female subjects using test Product B
The subjects selected for this study will be healthy females aged between 18 and 30 years, having mild to moderate acne and oily to mixed oily skin type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Indian female subjects.
- •Healthy Subjects 3.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4.Having oily to mixed oily skin type.
- •5.Having mild to moderate acne.
排除标准
- •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.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
结局指标
主要结局
Reduction in Acne (live/occurring) and sebum reduction
时间窗: Baseline, Day14, Day28
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.