To evaluate the safety and efficacy of the Test Product A in terms of noncomedogenic effect on healthy human 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
Primary Objective: The objective of this study will be to evaluate the safety and efficacy of the Test Product A in terms of non-comedogenic effect on healthy human subjects
Secondary Objective: The secondary objective of this study will be to evaluate skin pH balance.
The evaluation will be performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Skin pH metry
POPULATION: 36 females subjects will be selected for the study.
The subjects selected for this study will be healthy females, aged between 18 and 35 years, presenting oily or mixed oily skin on the face (visual assessment by dermatologist).
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 35.00 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 mixed oily or oily skin on the face.
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
Non-comedogenic effect
时间窗: Baseline, Day 14, Day 28
次要结局
- Skin pH balance(Baseline, Day 14, Day 28)
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.