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

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Safe Sea sun lotion with jellyfish sting protection SPF 15
Nivea sun, caring sun lotion SPF 15
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring Jellyfish, Cyanea sp, Safe Sea, Prevention, treatment, Pain relief, Prevention of pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Oslo, Biologisk Stasjon Drøbak

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Safe Sea™ jellyfish sting inhibitor (barrier, or "repellent") lotion

Regular sun lotion

Outcomes

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.
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

Full Information

First Posted
June 5, 2008
Last Updated
June 3, 2011
Sponsor
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT00693641
Brief Title
Efficiency of a Jellyfish Sting Inhibitor Sun Lotion and Protocols for Jellyfish Sting Pain Relief
Official Title
Efficiency of a Jellyfish Sting Inhibitor Sun Lotion and Protocols for Jellyfish Sting Pain Relief
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oslo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Jellyfish, Cyanea sp, Safe Sea, Prevention, treatment, Pain relief, Prevention of pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Safe Sea™ jellyfish sting inhibitor (barrier, or "repellent") lotion
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Regular sun lotion
Intervention Type
Other
Intervention Name(s)
Safe Sea sun lotion with jellyfish sting protection SPF 15
Other Intervention Name(s)
SunCare sunlotion with jellyfish sting protection SPF 15
Intervention Description
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%.
Intervention Type
Other
Intervention Name(s)
Nivea sun, caring sun lotion SPF 15
Intervention Description
The amount of lotion applied to the skin before spreading is 2.00 mg.cm-²± 2.5%.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
Repeated jellyfish contact for total of 240 second or until pain occurs
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Erik Karlsen, Associate prof.
Organizational Affiliation
University of Oslo, Biologisk Stasjon Drøbak
Official's Role
Study Director
Facility Information:
Facility Name
University of Oslo, Biologisk Stasjon Drøbak
City
Biologveien 2
State/Province
Drøbak
ZIP/Postal Code
1440
Country
Norway

12. IPD Sharing Statement

Links:
URL
http://www.wemjournal.org/article/S1080-6032(04)70454-8/abstract
Description
Efficacy of a Jellyfish Sting Inhibitor in Preventing Jellyfish Stings in Normal Volunteers", Wilderness and Environmental Medicine, 15, 102 108 (2004)

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

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