To evaluate the in vivo efficacy and safety of a skin care formulation in terms of reduction in acne and reduction in sebum on healthy female subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction in acne & reduction in sebum
研究概览
简要总结
PRIMARY OBJECTIVE:To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of reduction in acne & reduction in sebum on healthy female subjects.
SECONDARY OBJECTIVE: To evaluate the efficacy and safety of a skin care formulation in terms of reduction in pores on healthy female subjects.
The evaluation is performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Sebumetry
POPULATION: 36 Female subjects will be selected for the study.
The subjects selected for this study will be healthy females, aged between 18 to 30 years having acne (at least 2 live acne), pores and oily to mixed oily skin type.
STUDY DURATION: 56 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
- Female
入选标准
- •)Indian female subjects 2)Healthy subjects 3) Skin is healthy on the studied anatomic unit 4) Having acne (at least 2 live acne), pores 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 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 & reduction in sebum
时间窗: Baseline, Day 1, Day 7, Day 14, Day 28, Day 56
次要结局
- Reduction in pores(Baseline, Day 1, Day 7, Day 14, Day 28, Day 56)
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.