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

Phase 4

Completed

• Conditions: Pain
• Interventions: Other: Safe Sea sun lotion with jellyfish sting protection SPF 15; Other: Nivea sun, caring sun lotion SPF 15

• Registration Number: NCT00693641
• Lead Sponsor: University of Oslo

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-09
• Study Start: 2008-07
• Primary Completion: 2009-12
• Status Verified: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-03
• Last Update Posted: 2011-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Safe Sea sun lotion with jellyfish sting protection SPF 15	Safe Sea™ jellyfish sting inhibitor (barrier, or "repellent") lotion
2	Nivea sun, caring sun lotion SPF 15	Regular sun lotion

Primary Outcome Measures

Name	Time	Method
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.	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).

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Oslo, Biologisk Stasjon Drøbak; 🇳🇴 Biologveien 2, Drøbak, Norway