A Double-Blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Rena ™ Activation Mist on Facial Skin Wrinkles.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Silicone skin replica analysis
研究概览
简要总结
To determine the effect of Activation Mist (AM) on skin wrinkles and appearance.
详细描述
This study aims to study the effects of Activation Mist ( AM) on skin wrinkles. It contains a proprietary blend of minerals and nutritional supplements which is patented as "Liquidized Infrared Negative Ion Activation Energy". Active ingredients include sodium bicarbonate, potassium bicarbonate, sodium carbonate, strontium carbonate, gold nanoparticles, calcium, germanium, selenium , zinc, sugar and water. When applied to the skin , it has been shown to reduce the appearance of wrinkles by stimulation of skin fibroblasts to produce new collagen while removing aging dermis cells, facilitate the production of fibrillin proteins and protect the skin from ultraviolet rays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.Male and female subjects aged 30 to 80 years of age with significant facial wrinkles as assessed by the study physician.
排除标准
- •Women who are pregnant or lactating.
- •Subjects with skin conditions that are deemed by the investigator to interfere with the results of this study , including but not limited to: uncontrolled acne, rosacea, atopic dermatitis.
- •Subjects with clinically significant cardiovascular, neurological, renal, endocrine or hematological abnormalities uncontrolled on current therapy.
- •Subjects with history of skin malignancy
- •Subjects with signs of recent sunburn
- •Use of any of the following medications, within 1 week specified of visit 1
- •Systemic steroids
- •Topical steroids used on the face
- •Topical facial preparations including but not limited to: salicylic acid and other acne products, tacrolimus, pimecrolimus.
结局指标
主要结局
Silicone skin replica analysis
时间窗: before and after 8 weeks of treatment
Silflo ™ vinyl silicone ( Cuderm Corp.) is applied to the skin areas to be studied and replicas obtained after letting it stand for 3- 5 minutes. The replica technique takes a negative copy of the skin surface which is analyzed by optical profilometry. Optical profilometry ( BioNet Inc.) uses light intensity to assess skin wrinkle texture by objective parameters ( e.g. spacing, breadth, shadows, num wrinkles) This will be performed before and after 8 weeks of treatment.
次要结局
- Wrinkle Score(every week for 8 weeks)
- Photographic evaluation(weekly for 8 weeks)