Safety and Effectiveness Evaluation of a New Moisturizer Formulation With Antioxidant, Anti-inflammatory and Anti-microbial Effects in the Prevention of a Diabetic Skin Dryness and Complications
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Skin texture
研究概览
简要总结
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications.
详细描述
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. This study aim to address the target population, subjects with controlled diabetes, to verify the improvement of texture, elasticity, and general appearance of the skin through the application of the cosmetic product Apotech®.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with controlled diabetes
- •Any phototype and all skin types
排除标准
- •Pregnant women
- •Subjects that not match the inclusion criteria
结局指标
主要结局
Skin texture
时间窗: 28 days
Standard guide for sensory claim substantiation - ASTM
Skin elasticity and visible cracking
时间窗: 28 days
Standard guide for sensory claim substantiation - ASTM
Skin general appearance
时间窗: 28 days
Standard guide for sensory claim substantiation - ASTM
Skin hydration
时间窗: 28 days
Standard guide for sensory claim substantiation - ASTM
次要结局
- Sensory evaluation of the product(28 days)