Prevention of Jellyfish Stings

Bites and Stings Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114894
• Other study ID #: 0311M54041
• Status: Completed
• Phase: Phase 3
• Start date: April 2004
• Est. completion date: February 2006

Study information

• Verified date: April 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bites and Stings

Intervention

Other:
• Safe Sea ™
Safe Sea ™ applied one time at 2 mg/cm2 coverage
• Placebo
Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage

Locations

Country	Name	City	State
United States	Dry Tortugas National Park	Key West	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boulware, David R, MD

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of jellyfish stings		during recreational saltwater exposure (~30 min)
Secondary	Occurrence of seabather's eruption		within 48 hours of saltwater exposure
Secondary	impact of body hair on jellyfish stings		after recreational saltwater exposure