NCT00114894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

June 17, 2005

Last Update Submit

July 28, 2026

Conditions

Bites and Stings

Keywords

JellyfishStingsMarineEnvenomationJellyfish stings

Outcome Measures

Primary Outcomes (1)

  • Incidence of jellyfish stings

    during recreational saltwater exposure (~30 min)

Secondary Outcomes (2)

  • Occurrence of seabather's eruption

    within 48 hours of saltwater exposure

  • impact of body hair on jellyfish stings

    after recreational saltwater exposure

Study Arms (2)

Safe Sea

EXPERIMENTAL
Other: Safe Sea ™

Placebo

SHAM COMPARATOR

Coppertone® SPF15 (Schering-Plough)

Other: Placebo

Interventions

Safe Sea ™OTHER

Safe Sea ™ applied one time at 2 mg/cm2 coverage

Safe Sea
PlaceboOTHER

Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers planning on snorkeling for 30 to 45 minutes.

You may not qualify if:

  • Pregnancy
  • Severe allergy to jellyfish
  • Allergy to any topical dermatologic product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dry Tortugas National Park

Key West, Florida, 33041, United States

Location

Related Publications (1)

  • Boulware DR. A randomized, controlled field trial for the prevention of jellyfish stings with a topical sting inhibitor. J Travel Med. 2006 May-Jun;13(3):166-71. doi: 10.1111/j.1708-8305.2006.00036.x.

    PMID: 16706948RESULT

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • David R Boulware, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2005

First Posted

June 20, 2005

Study Start

April 1, 2004

Primary Completion

January 1, 2006

Study Completion

February 1, 2006

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations

US(1)