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临床试验/NCT00114894
NCT00114894已完成3 期

Field Study of the Prevention of Jellyfish Stings With a Topical Sting Inhibitor

University of Minnesota2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2004年4月1日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Safe Sea ™ (Other)

Placebo

Sham Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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