Prospective, Double Blind, Randomized Phase II/III Study to Assess the Safety and Efficacy of SQIN™ on Xerosis in Adults Suffering of Mobility Impairment and/or Complete Paralysis Associated With Chronic Spinal Cord Injury.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Elasticity level (Self-assessment (5-level score)
研究概览
简要总结
In the general population, xerosis is often caused by external factors such as seasonal changes. In that case, the best way to relieve dry skin is to use a standard moisturizer. However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord injury, multiple sclerosis, Parkinson's, etc), xerosis is often severe and chronic because of the multiple causes (endogenous rather than exogenous ones) underlying such mobility impairment-related skin problems. This study is a double-blind, randomized study with positive control (active comparator) to assess the safety and efficacy of SQIN with CanSATs (Co-Activation of Natural Synergistically Acting Target-receptorS) technology on dry skin in patients suffering of paralysis.
详细描述
Xerosis is a medical term for dry skin. When it results in skin that is scaly and itchy, the condition is called pruritus. This occurs when natural moisture is drawn out of the skin. The skin needs moisture to protect itself. The best way to relieve dry skin normally, for those suffering of seasonal dry skin problems, is to use standard moisturizers. However, for those suffering of mobility problems due to age or paralysis (spinal cord injury, multiple sclerosis, Parkinson's, Alzheimer's, muscular dystrophy, amputation, cerebral palsy, or other comparable disorders), xerosis becomes severe and chronic because of the multiple causes (endogenous metabolic problems and dysfunctions rather than exogenous ones). SQIN with CanSATs technology is designed to act upon multiple mechanisms for enhanced protecting, moisturizing, and repairing effects. Based upon preliminary evidence, SQIN with CanSATs technology can thus elicit significantly superior effects compared with standard, commercially available moisturizers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paralyzed due to a spinal cord injury (traumatic or non-traumatic origin)
- •Chronically injured (at least 3 months post-injury)
- •Paraplegic or tetraplegic
- •18-75 years of age
- •Men and women
- •French-speaking
排除标准
- •Acute or subacute stage (within 1 day and 3 months post-injury)
- •Had tumor(s) (malignant or non-malignant) of the skin in the last five (5) years
- •Allergic or hypersensitive to any ingredient, investigational or control product
- •With psychiatric or mental disorder(s)
- •Children (younger than 18 year-old) or elderly (older than 75 year-old)
- •Not French-speaking
结局指标
主要结局
Elasticity level (Self-assessment (5-level score)
时间窗: 14 days
Self-assessment (5-level score) of the elasticity level of the skin before, during and after the treatment
Skin tolerance (Self-assessment of redness or itchiness problems)
时间窗: 14 days
Self-assessment of redness or itchiness problems during or after the treatment
Moisturizing level (Self-assessment (5-level score)
时间窗: 14 days
Self-assessment (5-level score) of dry skin conditions before, during and after the treatment
次要结局
未报告次要终点