PainPhase 4NCT00693641
Efficiency of a Jellyfish Sting Inhibitor Sun Lotion and Protocols for Jellyfish Sting Pain Relief
A Phase 4 study testing Safe Sea sun lotion with jellyfish sting protection SPF 15 and Nivea sun, caring sun lotion SPF 15 in people with Pain, run by University of Oslo at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Safe Sea sun lotion with jellyfish sting protection SPF 15 and Nivea sun, caring sun lotion SPF 15
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2008to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers
- men or women
- aged 18 or over
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
University of Oslo, Biologisk Stasjon Drøbak
Biologveien 2, Drøbak, 1440
About this study
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
- Being tested
- Safe Sea sun lotion with jellyfish sting protection SPF 15, Nivea sun, caring sun lotion SPF 15
- Keywords
- Jellyfish, Cyanea sp, Safe Sea, Prevention, treatment, Pain relief, Prevention of pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Sea sun lotion with jellyfish sting protection SPF 15Other
Also called SunCare sunlotion 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%.
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%.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Safe Sea™ jellyfish sting inhibitor (barrier, or "repellent") lotion Receives: Other: Safe Sea sun lotion with jellyfish sting protection SPF 15 |
| 2 | Placebo comparator | Regular sun lotion Receives: Other: Nivea sun, caring sun lotion SPF 15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Pain relief treatment will start after 10 minutes, repeat treatment after 30 minutes if VAS score > 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Investigators
- Hans Erik Karlsen, Associate prof., Study director, University of Oslo, Biologisk Stasjon Drøbak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693641
- Sponsor's protocol ID
- 2008-02-12-1 (UIO, BIOLOGEN)
- Other IDs
- 2008-001519-39 (SLV), 2008
- Status last verified
- Jun 2011
- First submitted
- 5 Jun 2008
- Last updated
- 6 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of a Jellyfish Sting Inhibitor Sun Lotion and Protocols for Jellyfish Sting Pain Relief
- ClinicalTrials.gov ID
- NCT00693641
- Acronym / sponsor ID
- 2008-02-12-1 (UIO, BIOLOGEN)
- Conditions
- Pain
- Keywords
- Jellyfish, Cyanea sp, Safe Sea, Prevention, treatment, Pain relief, Prevention of pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Safe Sea sun lotion with jellyfish sting protection SPF 15Safe Sea™ jellyfish sting inhibitor (barrier, or "repellent") lotion |
| 2 | Placebo comparator | Other: Nivea sun, caring sun lotion SPF 15Regular sun lotion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteers
- men or women
- aged 18 or over
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe Sea sun lotion with jellyfish sting protection SPF 15Also: SunCare sunlotion with jellyfish sting protection SPF 15Prevent 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 | 1 |
| Nivea sun, caring sun lotion SPF 15The amount of lotion applied to the skin before spreading is 2.00 mg.cm-²± 2.5%. | Other | 2 |
Primary outcome
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).
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Erik Karlsen, Associate prof. study director
University of Oslo, Biologisk Stasjon Drøbak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Safe Sea sun lotion with jellyfish sting protection SPF 15 and Nivea sun, caring sun lotion SPF 15 in people with Pain, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2011.