PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot)& radiant skin on healthy male & female subjects. SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms signs of ageing: minimize fine lines, smooth skin texture, reducing dark circles and improvement in hydration on healthy male & female subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Even skin tone,
研究概览
简要总结
Objective:
PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot), radiant skin and skin brightness on healthy male & female subjects.
SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms signs of ageing: minimize fine lines, smooth skin texture, reducing dark circles and improvement in skin hydration on healthy male & female subjects
Duration of study: 28 days study
Kinetics: T0, T+14 days and T+28 days
Population: 36 (18 Females & 18 Males) volunteers
The evaluation is performed using:
-
Subject’s Self Evaluation,
-
Dermatological Evaluation: Cosmetic Acceptability,
-
Dermatological Evaluation: Efficacy
-
Chromametry
-
Corneometry
-
CLBT (Color, Luminosity, Brightness, Transparency)
-
Cutometry
-
Tewametry
-
Sebumetry
10. Mexametry
11. Illustrative photographs of whole face & ¾ th face under diffused light
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
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Having dull skin and uneven skin tone
- •Having pigmentary spot on the face of grade 2 to grade 6 according to the Bazins atlas
- •Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas
- •Having visible under eye dark circle
- •Presenting Fitzpatrick skin type III to V with chromameter i.e. ITA° value between -30° & 41° on cheek bones.
排除标准
- •Having started, changed or interrupted one hormonal treatment during the past 3 months
- •Having started, changed or stopped her tobacco consumption in the previous 6 months
- •Having consumed caffeine-based products, 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 in the previous 6 months
- •Taking oral supplements with major or minor effect on whitening of skin
- •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 in the 2 weeks preceding the start of the study
- •Having applied products with a depigmenting/ whitening action in the 4 weeks preceding the start of the study
- •Having undergone physical and/or chemical treatments of the spots 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
Even skin tone,
时间窗: Baseline, 14 days and 28 days
reduction in pigmentation (dark spot), radiant skin and skin brightness, safety of a skin
时间窗: Baseline, 14 days and 28 days
次要结局
- Minimize fine(lines, smooth skin texture, reducing dark circles and improvement in skin hydration)