To evaluate and compare the in-vivo safety and efficacy of the skin care formulations in terms of reduction in Acne (live/occurring) on healthy female subjects
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Reduction in Acne
研究概览
简要总结
The objective of this study will be to evaluate and compare the in-vivo safety and efficacy of the skin care formulations in terms of reduction in Acne (live/occurring) on healthy female subjects.
Products: Regime1 and Regime 2
The evaluation is performed using: Subject Self Evaluation (SSE), Dermatological : Cosmetic Acceptability, Dermatological Evaluation: Efficacy
The study lasts 28 days following the first application of the regime on whole face.
POPULATION - 72 Females subjects will be selected for the study.
The subjects selected for this study are healthy females, aged between 18 and 30 years, having mild to moderate acne and oily to mixed oily skin type.
The study will be conducted in 2 groups.
I. Group A: This group will include 36 female subjects using Regime 1.
II. Group B: This group will include 36 female subjects using Regime 2.
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 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian female subjects
- •Healthy subjects
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4 Having mild to moderate acne and oily to mixed oily skin type.
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
时间窗: Baseline, Day 14, Day 28
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.