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Completed

NCT Number: NCT00693641

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Oslo, Biologisk Stasjon Drøbak

Biologveien 2, Drøbak, 1440, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Safe Sea sun lotion with jellyfish sting protection SPF 15

Other

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: SunCare sunlotion with jellyfish sting protection SPF 15

Nivea sun, caring sun lotion SPF 15

Other

The amount of lotion applied to the skin before spreading is 2.00 mg.cm-²± 2.5%.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Jun 9, 2008
Registry last updated
Jun 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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