To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of reduction in hyperpigmentation, skin glow and skin radiance 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
- 36
- 试验地点
- 1
- 主要终点
- Reduction in
研究概览
简要总结
OBJECTIVE :To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of reduction in hyperpigmentation (Acne PIH), skin glow & skin radiance on healthy female subjects
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Safety, Dermatological Evaluation: Efficacy, Mexametry, CLBT (Color, Luminosity, Brightness, Transparency), Illustrative Images of the whole face & 3/4th face under diffuse light
The study last 28 days following first application of the test product on the whole face.
POPULATION: 36 Female subjects will be selected for the study.
The subjects selected for this study are healthy females, aged between 18 and 30 years, having
hyperpigmentation (Acne PIH) dark spot.
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.
- •Healthy subjects
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
- •Having hyperpigmentation (Acne PIH) dark spot.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •â€¢ Having refused to give her assent by signing the consent form.
- •â€¢ Taking part in another study liable to interfere with this study.
- •â€¢ Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area.
- •â€¢ Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months).
- •â€¢ Having a progressive asthma (either under treatment or last fit in the last 2 years).
- •â€¢ Being epileptic.
- •â€¢ Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months).
- •â€¢ Having cutaneous hypersensitivity • Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex • Having known allergy to any of the Ingredient of the Test Product.
- •â€¢ 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 (the only medication permitted is paracetamol) • 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
时间窗: Baseline, Day14, Day28
hyperpigmentation (Acne PIH), improvement in skin glow & skin radiance
时间窗: Baseline, Day14, Day28
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.