The objective of this study will be to evaluate the in vivo safety and efficacy of skin care formulation in terms of reduction in melasma on healthy human 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 melasma
研究概览
简要总结
PRIMARY OBJECTIVE
The objective of this study will be to evaluate the in vivo safety and efficacy of skin care formulation in terms of reduction in melasma on healthy human subjects.
SECONDARY OBJECTIVE
The objective of this study will be to evaluate change in pigmentation, change in MELASQOL (quality of lifestyle) related to melasma, Cosmetic Acceptability on healthy human subjects.
The evaluation is performed using Dermatological Evaluation: Efficacy, Mexametry, Dermatological Evaluation: Cosmetic Acceptability, Subject Self Evaluation
The study lasts for 112 days following the first application of the product.
POPULATION : 36 (18 Females & 18 Males) subjectswill be selected for the study.
The subjects selected for this study will be healthy males and females aged 30 to 60 years*, having melasma.*
STUDY DURATION
Duration: 112 days following the first application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian Male and Female subjects
- •Healthy subjects
- •Skin is healthy on the studied anatomic unit
- •Human subjects with melasma.
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 not 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)
- •Having progressive asthma.
- •Being epileptic.
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Having cutaneous hypersensitivity
- •Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products.
- •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 consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements.
- •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
- •Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted).
结局指标
主要结局
Reduction in melasma
时间窗: Baseline, 28 days, 56 Days, 84 Days, 112 Days
次要结局
- Change in pigmentation, change in MELASQOL (quality of lifestyle) related to melasma, Cosmetic Acceptability(Baseline, 28 days, 56 Days, 84 Days, 112 Days)
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.