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

NCT ID: NCT00693641

Last Updated: 2011-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-06-30

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).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Safe Sea sun lotion with jellyfish sting protection SPF 15

Intervention Type: 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%.

2

Regular sun lotion

Group Type: PLACEBO_COMPARATOR

Nivea sun, caring sun lotion SPF 15

Intervention Type: OTHER

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

Interventions

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%.

Intervention Type: OTHER

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%.

Intervention Type: OTHER

Other Intervention Names

SunCare sunlotion with jellyfish sting protection SPF 15

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Rikshospitalet HF

Principal Investigators

Hans Erik Karlsen, Associate prof.

Role: STUDY_DIRECTOR

University of Oslo, Biologisk Stasjon Drøbak

Locations

University of Oslo, Biologisk Stasjon Drøbak

Biologveien 2, Drøbak, Norway

Countries

Norway

Other Identifiers

2008-001519-39 (SLV)

Identifier Type: -

Identifier Source: secondary_id

2008-02-12-1 (UIO, BIOLOGEN)

Identifier Type: -

Identifier Source: org_study_id