Evaluation of the Efficacy of the UVMune 400 Fluid Sunscreen on the Face Versus Usual Photoprotection Routine on Visible and Measurable Signs of Aging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Change in the dermatological assessment of skin signs on the face (Global score)
研究概览
简要总结
This experimental, randomized study aims at evaluating the preventative effect of a Sun Protection Factor (SPF) 50+ sunscreen (Anthelios UVMUNE 400 Fluid SPF 50+) with high Ultraviolet A (UVA) protection on clinical signs of skin aging.
详细描述
The study will be conducted in compliance with the protocol, current internal procedures and in the spirit of the International Council on Harmonisation (ICH) Topic E6(R2)5 ref: EMA/CHMP/ICH/135/1995, ICH Good Clinical Practice (GCP) Addendum Nov 2016 and applicable regulatory requirement.
Statistical plan: Tx represents the values observed at Time x, for each parameter and by subgroup. Quantitative variables, or those that can reasonably be treated as such, will be summarized using the minimum, maximum, measures of central tendency such as the mean and median & measures of dispersion such as the standard deviation (SD). Qualitative variables will be summarized in the form of counts and percentages.
For each parameter, a graphical representation of the means ±95% Confidence Interval (CI) will be produced to visually assess the evolution across time, by treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with signs of photo aging (Global score of at least 14)
- •All skin types
排除标准
- •Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site
- •Pregnant or breastfeeding women
- •Subject with known allergy to cosmetic products or to any ingredient of the sunscreen product
研究组 & 干预措施
Tested product group
Volunteers using the investigational product handed over to them
干预措施: Tested product group (Other)
Control group
Volunteers using their own sun protection routine
干预措施: Control group (Other)
结局指标
主要结局
Change in the dermatological assessment of skin signs on the face (Global score)
时间窗: Day0; Day84; Day168; Day252; Day336
Assessment of the skin parameters: Skin roughness \[absent (0), mild (2), moderate (4), severe (6)\]; Skin laxity \[absent (0), mild (2), moderate (4), severe (6)\]; Skin suppleness \[high(0), moderate (2),low (4), absent (6)\]; Skin radiance \[highly radiant (0), radiant (2), normal(4), dull(6), highly dull(8)\]; Pigmented spots \[absent (0), visible (2), highly visible (4)\]; Skin tone homogeneity \[homogeneous (0), non-homogeneous (2)\].
次要结局
- Dermatological assessment of skin signs on the face - Atlas Bazin, Flament (Global score)(Day0; Day84; Day168; Day252; Day336)