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

Study Overview
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Brief Summary
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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).

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

Conditions
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Pain

Intervention / Treatment
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* Other: Safe Sea sun lotion with jellyfish sting protection SPF 15
* Other: Nivea sun, caring sun lotion SPF 15


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Safe Sea™ jellyfish sting inhibitor (barrier, or repellent) lotion | Other: Safe Sea sun lotion with jellyfish sting protection SPF 15<br>* 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%.<br>* Other names: SunCare sunlotion with jellyfish sting protection SPF 15;|
| Placebo Comparator: 2<br>Regular sun lotion | Other: Nivea sun, caring sun lotion SPF 15<br>* The amount of lotion applied to the skin before spreading is 2.00 mg.cm-²± 2.5%.<br>|

What is the study measuring?
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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. | 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 | Measure Description | 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 |  | Pain relief treatment will start after 10 minutes, repeat treatment after 30 minutes if VAS score > 10. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jellyfish, Cyanea sp, Safe Sea, Prevention, treatment, Pain relief, Prevention of pain