NCT00693641

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 6, 2011

Status Verified

June 1, 2011

Enrollment Period

1.4 years

First QC Date

June 5, 2008

Last Update Submit

June 3, 2011

Conditions

Pain

Keywords

JellyfishCyanea spSafe SeaPreventiontreatmentPain reliefPrevention of pain

Outcome Measures

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.

    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 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

    Pain relief treatment will start after 10 minutes, repeat treatment after 30 minutes if VAS score > 10.

Study Arms (2)

1

ACTIVE COMPARATOR

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

Other: Safe Sea sun lotion with jellyfish sting protection SPF 15

2

PLACEBO COMPARATOR

Regular sun lotion

Other: Nivea sun, caring sun lotion SPF 15

Interventions

Safe Sea sun lotion with jellyfish sting protection SPF 15OTHER

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%.

Also known as: SunCare sunlotion with jellyfish sting protection SPF 15
1
Nivea sun, caring sun lotion SPF 15OTHER

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers
  • men or women
  • aged 18 or over

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo, Biologisk Stasjon Drøbak

Biologveien 2, Drøbak, 1440, Norway

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hans Erik Karlsen, Associate prof.

    University of Oslo, Biologisk Stasjon Drøbak

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 9, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2011

Last Updated

June 6, 2011

Record last verified: 2011-06

Locations

NO(1)