Efficiency of a Jellyfish Sting Inhibitor Sun Lotion and Protocols for Jellyfish Sting Pain Relief
June 3, 2011 updated by: University of Oslo
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Drøbak
-
Biologveien 2, Drøbak, Norway, 1440
- University of Oslo, Biologisk Stasjon Drøbak
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 1
Safe Sea™ jellyfish sting inhibitor (barrier, or "repellent") lotion
|
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 Names:
|
|
PLACEBO_COMPARATOR: 2
Regular sun lotion
|
The amount of lotion applied to the skin before spreading is 2.00 mg.cm-²± 2.5%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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).
|
Repeated jellyfish contact for total of 240 second or until pain occurs
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
Pain relief treatment will start after 10 minutes, repeat treatment after 30 minutes if VAS score > 10.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hans Erik Karlsen, Associate prof., University of Oslo, Biologisk Stasjon Drøbak
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (ACTUAL)
December 1, 2009
Study Completion (ACTUAL)
June 1, 2011
Study Registration Dates
First Submitted
June 5, 2008
First Submitted That Met QC Criteria
June 6, 2008
First Posted (ESTIMATE)
June 9, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 6, 2011
Last Update Submitted That Met QC Criteria
June 3, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-02-12-1 (UIO, BIOLOGEN)
- 2008-001519-39 (SLV)
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.