Prevention of Jellyfish Stings

NCT ID: NCT00114894

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-02-28

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.

Conditions

Bites and Stings

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Safe Sea

Group Type: EXPERIMENTAL

Safe Sea ™

Intervention Type: OTHER

Safe Sea ™ applied one time at 2 mg/cm2 coverage

Placebo

Coppertone® SPF15 (Schering-Plough)

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage

Interventions

Safe Sea ™

Safe Sea ™ applied one time at 2 mg/cm2 coverage

Intervention Type: OTHER

Placebo

Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R Boulware, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Dry Tortugas National Park

Key West, Florida, United States

Countries

United States

References

Boulware DR. A randomized, controlled field trial for the prevention of jellyfish stings with a topical sting inhibitor. J Travel Med. 2006 May-Jun;13(3):166-71. doi: 10.1111/j.1708-8305.2006.00036.x.

Reference Type: RESULT

PMID: 16706948 (View on PubMed)

Other Identifiers

0311M54041

Identifier Type: -

Identifier Source: org_study_id