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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693641
• Other study ID #: 2008-02-12-1 (UIO, BIOLOGEN)
• Secondary ID: 2008-001519-39 (
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2008
• Last updated: June 3, 2011
• Start date: July 2008
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

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%.
• 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%.

Locations

Country	Name	City	State
Norway	University of Oslo, Biologisk Stasjon Drøbak	Biologveien 2	Drøbak

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Repeated jellyfish contact for total of 240 second or until pain occurs	No
Secondary	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		Pain relief treatment will start after 10 minutes, repeat treatment after 30 minutes if VAS score > 10.	No

External Links

•   A Randomized, Controlled Field Trial for the Prevention of Jellyfish Stings With a Topical Sting Inhibitor", J Travel Med); 13: 166-171 (2006)
•   Efficacy of a Jellyfish Sting Inhibitor in Preventing Jellyfish Stings in Normal Volunteers", Wilderness and Environmental Medicine, 15, 102 108 (2004)