SunburnPhase 3NCT00326274
Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream
A Phase 3 study testing Helioblock® SX Cream in people with Sunburn, run by Loreal USA at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety potential of Helioblock® SX Cream as a sunscreen product in long term intermittent use conditions among pediatric subjects.. Each subject will be enrolled to participate for six months. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Sunburn
- What is being tested?
- Helioblock® SX Cream
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 2006to Nov 2006
- Phase
- Phase 3
- 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 6 months to 12 years
- All sexes
- Child
Who may be able to join
- Male or female subjects of any race or skin type, 6 months to 12 years of age inclusive, willing to use the test product intermittently for six months during outside activities
Who cannot join
- Subjects with known sensitivities to any of the study ingredients or subjects with a condition or in a situation, which in the Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or interfere with the subject's participation in the study.
- Subjects who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Testing Laboratories
Great Neck, New York, 11021
About this study
The purpose of this study is to determine the safety potential of Helioblock® SX Cream as a sunscreen product in long term intermittent use conditions among pediatric subjects.. Each subject will be enrolled to participate for six months. The test product should be applied every day that outdoor activities are planned, prior to any significant sun exposure during out-door activities (such as the beach, outdoor sport activities), or whenever the subject needs to be protected against sunburn or other damage due to the sun. A minimum of 14 days test product use and sun exposure is required.
- Conditions
- Sunburn
- Being tested
- Helioblock® SX Cream
- Medical subject headings
- Sunburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helioblock® SX CreamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety after 6 months intermittent use in a pediatric population
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startMay 2006
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SunburnStudies 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 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Loreal USA
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326274
- Sponsor's protocol ID
- PEN.750.04
- Status last verified
- Feb 2009
- First submitted
- 15 May 2006
- Last updated
- 11 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream
- ClinicalTrials.gov ID
- NCT00326274
- Acronym / sponsor ID
- PEN.750.04
- Conditions
- Sunburn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Loreal USAIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006
- First posted
- 16 May 2006 (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 this study is to determine the safety potential of Helioblock® SX Cream as a sunscreen product in long term intermittent use conditions among pediatric subjects.. Each subject will be enrolled to participate for six months. The test product should be applied every day that outdoor activities are planned, prior to any significant sun exposure during out-door activities (such as the beach, outdoor sport activities), or whenever the subject needs to be protected against sunburn or other damage due to the sun. A minimum of 14 days test product use and sun exposure is required.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- Male or female subjects of any race or skin type, 6 months to 12 years of age inclusive, willing to use the test product intermittently for six months during outside activities
Key exclusion criteria (2 listed)
- Subjects with known sensitivities to any of the study ingredients or subjects with a condition or in a situation, which in the Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or interfere with the subject's participation in the study.
- Subjects who are pregnant or lactating
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 |
|---|---|---|
| Helioblock® SX Cream | Drug | – |
Primary outcome
Long term safety after 6 months intermittent use in a pediatric population
Time frame: 6 months
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 11 Feb 2009.
Related trials for Sunburn
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Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Helioblock® SX Cream in people with Sunburn, run by Loreal USA at 1 site in United States.
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 1 inclusion and 2 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 11 Feb 2009. 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 United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Long term safety after 6 months intermittent use in a pediatric population (time frame: 6 months). 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 11 Feb 2009.