Exploratory Study to Assess Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream in Women After 2 Months of Daily Use, Under Dermatological Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Assessment of skin network (SRa parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)
研究概览
简要总结
The aim of the study is to determine the efficacy of the investigational product "Cream " :
- on skin network after 56 days of daily application
- on biological parameters linked to cellular communication involved in senescence
- on sebum composition (metagenomics and metabolomics analysis)
详细描述
This study will be conducted as a monocentric, randomized (for side of product application on forearms), open trial.
4 visits are planned:
- Visit 1 - Inclusion (D1)
- Visit 2 - Follow-up visit (D29), a window of +72 hours is allowed for this evaluation,
- Visit 3 - End of the application period (D57), a window of +72 hours is allowed for this evaluation
- Visit 4 - Follow-up visit (D7 post-biopsies +/- 24h)
For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum.
The study duration for each subject will be 67 days maximum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •sensitive skin (declaratory judgment)
- •face skin type: combination to normal skin
- •presenting wrinkles and/or finelines on the whole face
- •displaying saggy skin on the face (loss of firmness)
- •presenting a lack of skin radiance, dull complexion and an inhomogeneous skin on the face
排除标准
- •Related to the treatment/product:
- •having had any surgery, chemical or significant invasive dermo-treatment on the experimental area considered by the Investigator liable to interfere with the study data
- •having undergone techniques with aesthetic aim on study areas (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp etc.) or having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin etc.)
- •having applied products with an anti-aging action (Retinoic acid, retinol, retinaldehyde, A.H.A. etc.)
结局指标
主要结局
Assessment of skin network (SRa parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)
时间窗: Change from baseline to Day 57
SRa: Average roughness (mm). Average variations in amplitude of the relief integrated into the studied surface.
Assessment of sebum metabolites' composition
时间窗: Change from baseline to Day 57
Metabolomics analysis from sebum samples using mass spectrometry
Assessment of skin metagenomic composition
时间窗: Change from baseline to Day 57
Metagenomics analysis from sebum samples using targeted DNA sequencing
Expression of cellular communication markers linked to senescence
时间窗: Day 57
RNA expression from skin biopsies using RNA-Seq
Assessment of skin network (SRq parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)
时间窗: Change from baseline to Day 57
SRq: Roughness with regards to the average quadratic plan (mm).
次要结局
未报告次要终点