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CompletedNCT00326274Updated Feb 11, 2009

Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream

A Phase 3 interventional study of Helioblock® SX Cream in Sunburn, sponsored by Loreal USA. Completed at 1 site in United States. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2009-02-11.

Sponsored by Loreal USA · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Allocation
Non-randomized
Ages
6 Months to 12 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sunburn

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03

In context

Sunburn

29 studies on the registry are indexed under Sunburn; 2 are open to participants now.

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Lead sponsor

Loreal USA is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 12 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • DrugHelioblock® SX Cream
06

What researchers measure

Primary outcomes

  1. Long term safety after 6 months intermittent use in a pediatric population

    Time frame: 6 months

07

Study locations

1 site
  • Research Testing Laboratories
    Great Neck, New York 11021, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2006, a primary completion of Nov 2006 and a completion of Nov 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2006
First posted
May 16, 2006
Start
May 2006
Primary completionActual
Nov 2006
Completion
Nov 2006
Last update
Feb 11, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00326274
Lead sponsor
Loreal USA
First posted
May 16, 2006
Start date
May 2006
Primary completion
Nov 2006
Completion
Nov 2006
Last update
Feb 11, 2009
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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