- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00114894
Prevention of Jellyfish Stings
Field Study of the Prevention of Jellyfish Stings With a Topical Sting Inhibitor
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Florida
-
Key West, Florida, United States, 33041
- Dry Tortugas National Park
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: David R Boulware, MD, University of Minnesota
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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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