Efficacy Evaluation of the Anti-ageing Effect of a Cosmetic Active Versus Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Seneque SA
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Wrinkles
研究概览
简要总结
The study aims at evaluating skin wrinkling, puffiness and fatigue and dark circle appearance on asian and african-american healthy volunteer cohorts receiving a cosmetic formulation containing NMN (2%). The product will be evaluated after 28 and 56 days of twice-daily application in comparison with a reference cosmetic formulation using clinical scoring under dermatological control. Cosmetic acceptability and future use will also be subjectively evaluated by analysis of the subjects answers to an evaluation questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy subject
- •Subject having given her free informed, written consent
- •Subject willing to adhere to the protocol and study procedures
- •Subject with normal frontal temperature lower than 37.5°c/100.4°F
- •Subject has read and understood the information given by the investigator related to protection against Novel Coronavirus 19 and necessity to contact the investigator in case of any suspicion of COVID related manifestation (increase of frontal temperature, cough, sore muscles, weakness...) during the study
排除标准
- •Pregnant or nursing woman or woman planning to get pregnant during the study
- •Start, stop or change in hormonal treatment (including contraceptive pill) <1.5 months
- •Cutaneous pathology on the study zone (face)
- •Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous efficacy of the study product
- •Subject having undergone a surgery under general anesthesia within the previous month
- •Know allergy to certain cosmetic or dermato-pharmaceutic products
- •Subject having done injections on face and/or a lifting
- •Excessive exposure to sunlight or UV-rays within the month preceding the study
结局指标
主要结局
Wrinkles
时间窗: Change from baseline (day 0) at days 28 and 56 of application
clinical grading under dermatological control using 1) a 7 points Visual scale of Bazin from absence (0) to pronounced wrinkles (6) for the Asian panel and 2) a 5 points Visual scale of Bazin from absence (0) to pronounced wrinkles (4) for the Afro-American panel
Relaxed features
时间窗: Change from baseline (day 0) at days 28 and 56 of application
clinical grading under dermatological control using a 11 points Non structured scale from relaxed features (0) to looking tired (10) for both panels
Eye bags
时间窗: Change from baseline (day 0) at days 28 and 56 of application
clinical grading under dermatological control using 1) a 7 points Visual scale of Bazin from absence (0) to pronounced bags (6) for the Asian panel and 2) a 6 points Visual scale of Bazin from absence (0) to pronounced bags (5) for the Afro-American panel
Dark circles
时间窗: Change from baseline (day 0) at days 28 and 56 of application
clinical grading under dermatological control using 1) a 6 points Visual scale of Dermscan from absence (0) to important dark circles (6) for the Asian panel and 2) a 5 points Visual scale of Dermscan from absence (0) to important dark circles (4) for the Afro-American panel
次要结局
- Subjective evaluation of the product agreeableness and its effects on skin texture, moisture, puffiness, brightness, youth, swelling, wrinkling, radiance and tone.(At day 56 of application)