To evaluate the in vivo safety and efficacy of Skin care formulation in terms of reduction in acne breakouts and redness on healthy human 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) breakouts and redness
研究概览
简要总结
PRIMARY OBJECTIVE: To evaluate the in-vivo safety and efficacy of Skin care formulation in terms of reduction in acne (live/occurring) breakouts and redness on healthy human subjects.
SECONDARY OBJECTIVE: To evaluate the in-vivo safety and efficacy of a skin care formulation in terms of reduction in pore size, sebum, white heads and blackheads on healthy human
The evaluation is performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Sebumetry, Illustrative Images of the whole face & 3/4th face under diffuse light
POPULATION: 36 Female and Male subjects will be selected for the study (30 completed cases).
The subjects selected for this study are healthy males & females, aged between 18-30 years of age having mild to moderate acne on face or body/back and oily to mixed oily skin type, visible pores, white heads and blackheads.
STUDY DURATION: 28 days following the first application of the product.
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
- All
入选标准
- •Indian male and female subjects.
- •Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having oily to mixed oily skin type.
- •Having mild to moderate acne on face or body/back.
- •Having visible pores.
- •Having white heads and black heads.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give his/her assent by not signing the consent form and Informed consent form
- •Taking part in another study liable to interfere with this study
- •Being known diabetic case
- •Known asthma case
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Being known thyroid case
- •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 or corticosteroid by any route (the only medication permitted is paracetamol)
- •Known case of hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
结局指标
主要结局
Reduction in acne (live/occurring) breakouts and redness
时间窗: Baseline, Day 1, Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 21, Day 28
次要结局
- Reduction in pore size, sebum, white heads and blackheads(Baseline, Day 1, Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 21, Day 28)
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.