Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-04 @ 5:58 AM
Study NCT ID:
NCT00114894
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2005-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Jellyfish Stings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2005-06-17', 'studyFirstSubmitQcDate': '2005-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of jellyfish stings', 'timeFrame': 'during recreational saltwater exposure (~30 min)'}], 'secondaryOutcomes': [{'measure': "Occurrence of seabather's eruption", 'timeFrame': 'within 48 hours of saltwater exposure'}, {'measure': 'impact of body hair on jellyfish stings', 'timeFrame': 'after recreational saltwater exposure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Jellyfish', 'Stings', 'Marine', 'Envenomation', 'Jellyfish stings'], 'conditions': ['Bites and Stings']}, 'referencesModule': {'references': [{'pmid': '16706948', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nClown 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers planning on snorkeling for 30 to 45 minutes.\n\nExclusion Criteria:\n\n* Pregnancy\n* Severe allergy to jellyfish\n* Allergy to any topical dermatologic product'}, 'identificationModule': {'nctId': 'NCT00114894', 'briefTitle': 'Prevention of Jellyfish Stings', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Field Study of the Prevention of Jellyfish Stings With a Topical Sting Inhibitor', 'orgStudyIdInfo': {'id': '0311M54041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safe Sea', 'interventionNames': ['Other: Safe Sea ™']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo', 'description': 'Coppertone® SPF15 (Schering-Plough)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Safe Sea ™', 'type': 'OTHER', 'description': 'Safe Sea ™ applied one time at 2 mg/cm2 coverage', 'armGroupLabels': ['Safe Sea']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33041', 'city': 'Key West', 'state': 'Florida', 'country': 'United States', 'facility': 'Dry Tortugas National Park', 'geoPoint': {'lat': 24.55524, 'lon': -81.78163}}], 'overallOfficials': [{'name': 'David R Boulware, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}