Prevention of Jellyfish Stings

This study has been completed.
Sponsor:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00114894
First received: June 17, 2005
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Bites and Stings
Other: Safe Sea ™
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Field Study of the Prevention of Jellyfish Stings With a Topical Sting Inhibitor

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Incidence of jellyfish stings [ Time Frame: during recreational saltwater exposure (~30 min) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of seabather's eruption [ Time Frame: within 48 hours of saltwater exposure ] [ Designated as safety issue: No ]
  • impact of body hair on jellyfish stings [ Time Frame: after recreational saltwater exposure ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2004
Study Completion Date: February 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Safe Sea Other: Safe Sea ™
Safe Sea ™ applied one time at 2 mg/cm2 coverage
Sham Comparator: Placebo
Coppertone® SPF15 (Schering-Plough)
Other: Placebo
Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114894

Locations
United States, Florida
Dry Tortugas National Park
Key West, Florida, United States, 33041
Sponsors and Collaborators
Boulware, David R, MD
Investigators
Principal Investigator: David R Boulware, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
Publications:
Responsible Party: David R. Boulware, University of Minnesota
ClinicalTrials.gov Identifier: NCT00114894     History of Changes
Other Study ID Numbers: 0311M54041
Study First Received: June 17, 2005
Last Updated: August 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Jellyfish
Stings
Marine
Envenomation
Jellyfish stings

Additional relevant MeSH terms:
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on October 01, 2014