To evaluate the in vivo efficacy and safety of a skin care regime in terms of reduction in hyperpigmentation, Acne PIH, improvement in Skin brightness, skin tone evenness and skin texture on healthy female subjects
试验速览
- 阶段
- 不适用
- 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 hyperpigmentation (Acne PIH), improvement in Skin brightness, skin tone evenness and skin texture
研究概览
简要总结
OBJECTIVE - To evaluate the in-vivo efficacy andsafety of a skin care regime in terms of reduction in hyperpigmentation (AcnePIH), improvement in Skin brightness, skin tone evenness and skin texture onhealthy female subjects for product coded:
The evaluation will be performed using, SubjectSelf Evaluation, Dermatological Evaluation: Cosmetic Acceptability, DermatologicalEvaluation: Efficacy, Mexametry, Chromametry, Corneometry
POPULATION-72 (36 for test regime and 36 forplacebo regime) Female subjects will be selected for the study.
The subjects selected for this study are healthyfemales, aged between 18 and 40 years old, having normal skin type with visibleAcne PIH (at least one spot of 3mm or more) and dull skin.
STUDY DURATION- 28 days following the firstapplication of the test product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 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 normal skin type 5)Having visible Acne PIH 6)Having dull skin.
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 hyperpigmentation (Acne PIH), improvement in Skin brightness, skin tone evenness and skin texture
时间窗: Baseline, Day 14 and Day 28
次要结局
未报告次要终点