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Prevention of Jellyfish Stings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00114894
Recruitment Status : Completed
First Posted : June 20, 2005
Last Update Posted : April 25, 2023
Sponsor:
Information provided by:
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bites and Stings Other: Safe Sea ™ Other: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Field Study of the Prevention of Jellyfish Stings With a Topical Sting Inhibitor
Study Start Date : April 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : February 2006
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of jellyfish stings [ Time Frame: during recreational saltwater exposure (~30 min) ]

Secondary Outcome Measures :
  1. Occurrence of seabather's eruption [ Time Frame: within 48 hours of saltwater exposure ]
  2. impact of body hair on jellyfish stings [ Time Frame: after recreational saltwater exposure ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114894


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

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Responsible Party: David R. Boulware, University of Minnesota
ClinicalTrials.gov Identifier: NCT00114894    
Other Study ID Numbers: 0311M54041
First Posted: June 20, 2005    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023
Keywords provided by University of Minnesota:
Jellyfish
Stings
Marine
Envenomation
Jellyfish stings
Additional relevant MeSH terms:
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Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries