PRIMARY OBJECTIVE: To evaluate and compare the in-vivo efficacy and safety of two skin regimes in terms of reduction in dark spots (Lightens the pigmentation of selected dark spots-age spots), improvement in skin moisturization upto 48 hours, improvement in skin brightening , improvement in skin firmness, elasticity, skin radiance, skin glow, skin softness, prevention of water loss from skin (TEWL parameter) and tan reduction, reduction in fine line and wrinkles and clear skin in terms of reduction in dark spot and on healthy female subjects. SECONDARY OBJECTIVE: To evaluate the subject feedback for product efficacy in terms of clear skin (basis reduction in dark spots)
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 dark spots (Lightens the pigmentation of selected dark spots-age spots), improvement in skin moisturization upto 48 hours, improvement in skin brightening , improvement in skin firmness, elasticity, skin radiance, skin glow, skin softness, prevention of water loss from skin (TEWL parameter) and tan reduction, reduction in fine line and wrinkles and clear skin in terms of reduction in dark spot
研究概览
简要总结
PRIMARY OBJECTIVE: To evaluate and compare the in-vivo efficacy and safety of two skin regimes in terms of reduction in dark spots (Lightens the pigmentation of selected dark spots-age spots), improvement in skin moisturization upto 48 hours, improvement in skin brightening , improvement in skin firmness, elasticity, skin radiance, skin glow, skin softness, prevention of water loss from skin (TEWL parameter) and tan reduction, reduction in fine line and wrinkles and clear skin in terms of reduction in dark spot and on healthy female subjects.
SECONDARY OBJECTIVE: The seconday objective of the study will be to evaluate the subject feedback for product efficacy in terms of clear skin (basis reduction in dark spots).
The evaluation is performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Cutometry, Corneometry, Mexametry, Chromametry, CLBT (Color, Luminosity, Brightness, Transparency), Tewametry, Illustrative photographs of face under diffused light
The study lasts 56 days following the first application of the test products on the whole face.
72 Females subjects will be selected for the study.
The subjects selected for this study are healthy females, aged between 35 and 55 years old, having normal skin type with Age Related Dark Spots (at least 3.5mm in size), dry skin and dull and tanned skin.
The study will be conducted in 2 groups.
Group A: This group will include 36 female subjects using Regime (Product A to Product E).
Group B: This group will include 36 female subjects using Regime (Product F and Product G).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian female subjects 2)Having dry skin.
- •Having normal skin type with Age Related Dark Spots.
- •Having dull and tanned skin.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give her assent by signing the consent form.
- •Taking part in another study liable to interfere with this study.
- •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)Being epileptic 7)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8)Having cutaneous hypersensitivity 9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex 10) 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) 11)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 13)Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted).
结局指标
主要结局
Reduction in dark spots (Lightens the pigmentation of selected dark spots-age spots), improvement in skin moisturization upto 48 hours, improvement in skin brightening , improvement in skin firmness, elasticity, skin radiance, skin glow, skin softness, prevention of water loss from skin (TEWL parameter) and tan reduction, reduction in fine line and wrinkles and clear skin in terms of reduction in dark spot
时间窗: Baseline, 48 hours, 14 days, 28 days, 56 days.
次要结局
- clear skin (basis reduction in dark spots)(Baseline, 48 hours, 14 days, 28 days, 56 days.)
研究者
Dr Raji Patil
MASCOT-SPINCONTROL India Pvt. Ltd.