CTRI/2021/08/035607尚未招募不适用
To evaluate the in vivo efficacy and safety of a skin care formulation in terms of skin even tone, reduction in pigmentation (dark spots), radiant skin, skin brightening, skin moisturization, minimize fine lines and wrinkles, smooth skin and helps in reduction of dark circles on healthy male and female subjects.
Kama Ayurveda Pvt Ltd1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年2月9日最近更新:
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
- Efficacy of the product in terms of skin even tone, reduction in pigmentation (dark spots), radiant skin, skin brightening, skin moisturization, minimize fine lines and wrinkles, smooth skin and helps in reduction of dark circles
研究概览
简要总结
Objective: To evaluate the in vivo efficacy and safetyof a skin care formulation in terms of skin even tone, reduction inpigmentation (dark spots), radiant skin, skin brightening, skin moisturization,minimize fine lines and wrinkles, smooth skin and helps in reduction of darkcircles on healthy male and female volunteers
Duration of study: 28 days study
Kinetics: T0, T+14 days and T+28 days
Population: Group 1 36 volunteers
Group 2: 36 volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 35.00 Year(s) 至 52.00 Year(s)（—）
- 性别
- All
入选标准
- •Having dull skin and uneven skin tone Having pigmentary spot on the face Having Crows feet wrinkle of grade 2 Having visible under eye dark circle.
排除标准
- •Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months • Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…) Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or having applied self-tanning products in the week preceding the start of the study Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
- •Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months Having a suntanned skin on the studied areas which could interfere with the evaluations of the study For males, having not shaved their beard 24 hours prior to the day of measurement.
结局指标
主要结局
Efficacy of the product in terms of skin even tone, reduction in pigmentation (dark spots), radiant skin, skin brightening, skin moisturization, minimize fine lines and wrinkles, smooth skin and helps in reduction of dark circles
时间窗: T0, T14 days and T28 days
次要结局
- Safety(T0, T14 days and T28 days)
研究者
研究点 (1)
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