Prevention of Jellyfish Stings

Phase 3

Completed

• Conditions: Bites and Stings
• Interventions: Other: Safe Sea ™; Other: Placebo

• Registration Number: NCT00114894
• Lead Sponsor: Boulware, David R, MD

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-06-17
• Study First Submitted QC: 2005-06-17
• Study First Posted: 2005-06-20
• Primary Completion: 2006-01
• Study Completion: 2006-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safe Sea	Safe Sea ™	-
Placebo	Placebo	Coppertone® SPF15 (Schering-Plough)

Primary Outcome Measures

Name	Time	Method
Incidence of jellyfish stings	during recreational saltwater exposure (~30 min)

Secondary Outcome Measures

Name	Time	Method
Occurrence of seabather's eruption	within 48 hours of saltwater exposure
impact of body hair on jellyfish stings	after recreational saltwater exposure

Trial Locations

Locations (1)

Dry Tortugas National Park; 🇺🇸 Key West, Florida, United States