Prevention of Jellyfish Stings

April 24, 2023 updated by: Boulware, David R, MD

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Key West, Florida, United States, 33041
        • Dry Tortugas National Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Safe Sea
Safe Sea ™ applied one time at 2 mg/cm2 coverage
Sham Comparator: Placebo
Coppertone® SPF15 (Schering-Plough)
Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of jellyfish stings
Time Frame: during recreational saltwater exposure (~30 min)
during recreational saltwater exposure (~30 min)

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of seabather's eruption
Time Frame: within 48 hours of saltwater exposure
within 48 hours of saltwater exposure
impact of body hair on jellyfish stings
Time Frame: after recreational saltwater exposure
after recreational saltwater exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David R Boulware, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

June 17, 2005

First Submitted That Met QC Criteria

June 17, 2005

First Posted (Estimate)

June 20, 2005

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 0311M54041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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