An Open Label, Single Arm Clinical Study to Evaluate the healing activity of Wundschutzgel in Sunburn as example of light burns
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- NUTRIN GmbH
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Reduction in Sunburn measured as change in VAS Score
研究概览
简要总结
Sunburn is a radiation burn to the skin caused by too much exposure to the sun’s ultraviolet (UV) rays or artificial sources such as tanning beds. The biggest risk factors for sunburn is the amount of time the skin is exposed to UV rays, plus the intensity. Many factors such as time of day, medications, ozone depletion, high altitude, clear skies, and skin phototypes influence sunburns. An increase in the number of sunburns someone obtains is directly related to an increase in the risk of skin cancer. Therefore, by fully understanding the cause, treatment, and prevention of sunburns, patients can drastically decrease their risk of skin cancers. This will improve their quality of life. Additionally, by preventing sunburn, patients can reduce the solar effects of aging, which can lead to better cosmetic results.
The assessment will be done on day 0 and day 5 for the change in VAS score, Erythema, and elasticity, and DLQI assessment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age from 18 to 65 years 2.If female with childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
- •3.Subjects that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
- •4.Subjects willing to avoid participation in any other interventional clinical trial for the duration of the study.
排除标准
- •1.Females that are pregnant, breast feeding, or planning to get pregnant during the study.
- •2.Patients that have participated in any other interventional clinical trial in the previous 30 days.
- •3.Patients with known sensitivity to any of the constituents of the investigational product.
- •4.Any person suffering from heavily bleeding or weeping wound.
结局指标
主要结局
Reduction in Sunburn measured as change in VAS Score
时间窗: Baseline (day 0) and Day 5
次要结局
- Change in skin Elasticity(Baseline (day 0) and Day 5)
- Change in skin Erythema(Baseline (day 0) and Day 5)
- QOL changes to be measured as DLQI(Baseline (day 0) and Day 5)