Prevention of Jellyfish Stings

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bites and Stings

Intervention / Treatment
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* Other: Safe Sea ™
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers planning on snorkeling for 30 to 45 minutes. Exclusion Criteria: Pregnancy Severe allergy to jellyfish Allergy to any topical dermatologic product

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safe Sea<br> | Other: Safe Sea ™<br>* Safe Sea ™ applied one time at 2 mg/cm2 coverage<br>|
| Sham Comparator: Placebo<br>Coppertone® SPF15 (Schering-Plough) | Other: Placebo<br>* Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of jellyfish stings |  | during recreational saltwater exposure ( 30 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of seabather's eruption |  | within 48 hours of saltwater exposure | 
| impact of body hair on jellyfish stings |  | after recreational saltwater exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jellyfish, Stings, Marine, Envenomation, Jellyfish stings