Field Study of the Prevention of Jellyfish Stings With a Topical Sting Inhibitor
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Incidence of jellyfish stings
研究概览
简要总结
Jellyfish stings are a common occurrence among ocean-goers worldwide with an estimated 150 million envenomations annually. Fatalities and hospitalizations occur annually, particularly in the Indo-Pacific regions. A new topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. The field effectiveness is unknown. This is a field test to determine the real world effectiveness.
详细描述
Jellyfish stings are a common occurrence among ocean-goers worldwide with an estimated 150 million envenomations annually. Fatalities and hospitalizations occur annually, particularly in the Indo-Pacific regions. A new topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings.
Clown fish inhabit within the tentacles of sea anemones, which have stinging cells similar to those of jellyfish, yet clown fish are not stung by the sea anemones. In controlled laboratory environments, the jellyfish sting inhibitor, Safe Sea™ when applied to volunteers' arms, prevented 100% of Chrysaora fuscescens stings and 70% of Chiropsalmus quadrumanus stings. Of the C. quadrumanus stings that occurred, their intensity was diminished. The field effectiveness is unknown. This is a field test to determine the real world effectiveness of Safe Sea to prevent jellyfish stings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers planning on snorkeling for 30 to 45 minutes.
排除标准
- •Pregnancy
- •Severe allergy to jellyfish
- •Allergy to any topical dermatologic product
研究组 & 干预措施
Safe Sea
干预措施: Safe Sea ™ (Other)
Placebo
Coppertone® SPF15 (Schering-Plough)
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of jellyfish stings
时间窗: during recreational saltwater exposure (~30 min)
次要结局
- Occurrence of seabather's eruption(within 48 hours of saltwater exposure)
- impact of body hair on jellyfish stings(after recreational saltwater exposure)
