The objective of this study is to evaluate the non-comedogenic effect of skin care formulation, skin lightening face serum, on healthy human 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
- Non-comedogenic effect
研究概览
简要总结
OBJECTIVE: The objective of this study is toevaluate the non-comedogenic effect of skin care formulation, skin lightening face serum, on healthy human female subjects. The evaluation is performed using:Dermatologist Evaluation Efficacy: (Counting of total lesions ), Sebumetry, Subject Self Evaluation (SSE) Questionnaire (Comedogenic Effect& Safety), Subject Self Evaluation (SSE) Questionnaire (Cosmetic Appeal), Dermatological Evaluation: Safety
POPULATION: 36 female subjects are selected for the study*.**-*Enrollment: 36 female subjects
*-*Completed: 30 female subjects
*The subjects selected for this study are healthy females, aged between 18 and 35 years,*presenting with oily or mixed oily skin on the face and presenting with mild to moderate acne.
STUDY DURATION: 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 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian female subjects 2Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having oily or mixed oily skin type on the face.
排除标准
- •1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give her assent by not signing the consent form 3 Taking part in another study liable to interfere with this study 4 Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5 Having a progressive asthma (either under treatment or last fit in the last 2 years) 6 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Being epileptic.
- •9 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 10 Having cutaneous hypersensitivity.
- •11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •13 Having changed her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
结局指标
主要结局
Non-comedogenic effect
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.