Efficiency of a Jellyfish Sting Inhibitor Sun Lotion and Protocols for Jellyfish Sting Pain Relief

This study has been completed.
Sponsor:
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00693641
First received: June 5, 2008
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

The purpose of the study is to investigate the effectiveness of a sun lotion containing a specific Jellyfish sting inhibitor versus regular sun lotions as controls. In addition, to investigate the effectiveness of hot/cold immersion for the treatment of Cyanea sp stings versus local pain relief with prescription free pharmaceutical drug (Xylocain 30 mg/ml (3%) lidocain).


Condition Intervention Phase
Pain
Other: Safe Sea sun lotion with jellyfish sting protection SPF 15
Other: Nivea sun, caring sun lotion SPF 15
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficiency of a Jellyfish Sting Inhibitor Sun Lotion and Protocols for Jellyfish Sting Pain Relief

Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • The purpose of the study is to investigate the effectiveness of a sun lotion containing a specific Jellyfish sting inhibitor versus regular sun lotions or no protection at all when in contact with Cyanea SP. [ Time Frame: Repeated jellyfish contact for total of 240 second or until pain occurs ] [ Designated as safety issue: No ]
    We want to find out how much longer it takes before you get stung if one at all gets stung when you have a protective layer on the skin. We also want to find out if the reduction in pain is significantly less when the skin has jellyfish protection using visual analog scale (VAS).


Secondary Outcome Measures:
  • Investigate the effectiveness of hot/cold immersion for the treatment of Cyanea sp stings versus local pain relief with prescription free pharmaceutical drugs called Xylocain with lidocaine [ Time Frame: Pain relief treatment will start after 10 minutes, repeat treatment after 30 minutes if VAS score > 10. ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: July 2008
Study Completion Date: June 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Safe Sea™ jellyfish sting inhibitor (barrier, or "repellent") lotion
Other: Safe Sea sun lotion with jellyfish sting protection SPF 15
Prevent or significantly reduce jellyfish sting using sun lotion with a jellyfish sting inhibitor. The amount of lotion applied to the skin before spreading is the same as for regular sun lotion 2.00 mg.cm-²± 2.5%.
Other Name: SunCare sunlotion with jellyfish sting protection SPF 15
Placebo Comparator: 2
Regular sun lotion
Other: Nivea sun, caring sun lotion SPF 15
The amount of lotion applied to the skin before spreading is 2.00 mg.cm-²± 2.5%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers
  • men or women
  • aged 18 or over

Exclusion Criteria:

  • People with atopic diseases, e.g., asthma, allergic rhinorrhea or rhinitis, hay fever, or atopic skin inflammation
  • People who suffer from skin diseases in the testing regions or whose inner forearms are too hairy to allow for interpretation of the test
  • People who have used any medical or cosmetic product on either arm for 48 hours before the start of the experiment
  • People who are taking antihistamines or steroids
  • Subjects with medical conditions which, in the opinion of the investigator, pose risks that would prohibit participating
  • Subjects with a history of keloid formation will be excluded from the Jellyfish protocol
  • Subjects with allergy to lidocain or other local pain substances

If the arms contain hair that might reduce the jellyfish tentacle contact with the skin, the arm must be shaved in advance, so the skin has no sign of piling or any skin damage before the test.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693641

Locations
Norway
University of Oslo, Biologisk Stasjon Drøbak
Biologveien 2, Drøbak, Norway, 1440
Sponsors and Collaborators
University of Oslo
Investigators
Study Director: Hans Erik Karlsen, Associate prof. University of Oslo, Biologisk Stasjon Drøbak
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Physician Kim Alexander Tønseth, Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00693641     History of Changes
Other Study ID Numbers: 2008-02-12-1 (UIO, BIOLOGEN), 2008-001519-39 (SLV)
Study First Received: June 5, 2008
Last Updated: June 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo:
Jellyfish
Cyanea sp
Safe Sea
Prevention
treatment
Pain relief
Prevention of pain

Additional relevant MeSH terms:
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on August 01, 2014