Prevention of Jellyfish Stings

• Sponsor: Boulware, David R, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT00114894
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

• Study Type: Interventional
• 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: Apr 1, 2004
• Actual Primary Completion Date: Jan 1, 2006
• Actual Study Completion Date: Feb 1, 2006

Arms and Interventions

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

Primary Outcome Measures

1. Incidence of jellyfish stings [during recreational saltwater exposure (~30 min)]

Secondary Outcome Measures

1. Occurrence of seabather's eruption [within 48 hours of saltwater exposure]

2. impact of body hair on jellyfish stings [after recreational saltwater exposure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00114894
• Other Study ID Numbers: 0311M54041
• First Posted: Jun 20, 2005
• Last Update Posted: Jun 4, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by , ,: Jellyfish; Stings; Marine; Envenomation; Jellyfish stings
• Additional relevant MeSH terms: Bites and Stings

Study Results

No Results Posted as of Jun 4, 2020