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CompletedNCT01021787Updated Jun 14, 2011

Dermal Penetration of the Titanium Dioxide in Anthelios SX SPF40 Cream

A Phase 4 interventional study of Titanium dioxide in Sunburn, sponsored by Loreal USA. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-14.

Sponsored by Loreal USA · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To determine the penetration of micronized and pigmentary TiO2 in Formulas 283419 2 and 760.001 into the stratum corneum of Compromised (Induced Sunburn) human skin via skin stripping of human subjects.

02

Conditions studied

  • Sunburn

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Keywords

  • Sun Protection
03

In context

Sunburn

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

This study's enrollment of 26 is below the median of 54 across 26 interventional studies indexed under Sunburn.

Browse Sunburn studies →

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
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • All subjects must:

    1. be between the ages of 18 and 65.
    2. agree to not participate in any other product evaluations or clinical evaluations during the course of this study.
    3. have read, understood and signed an Form.
    4. have intact skin in the treatment area.
    5. have fair skin - Skin Types I, or II - as defined in Appendix II.
    6. be able to understand and willing to follow all study procedures and restrictions.

Exclusion criteria

Exclusion Criteria:

Subjects will be excluded from participating in the study if they:

  1. are female and are pregnant or lactating [must be using an acceptable method of if of child bearing potential].*
  2. exhibit any visible symptoms of skin disease, such as psoriasis or eczema, or skin abnormality (including active dermal lesions, uneven skin tone or scars) which might interfere with interpretation of the study results. The presence of nevi, blemishes, or moles will be acceptable if, in the Investigator's judgement, they will not interfere with the study results or skin stripping procedures.
  3. have a history of allergic responses to sunscreens or other products similar to those included in this study.
  4. have very dry or scaly skin on the test site.
  5. have diabetes.
  6. have a history of abnormal responses to sunlight, such as a phototoxic or photoallergic response.
  7. have an existing sunburn or suntan, or been to a tanning booth which would interfere with interpretation of the study results.
  8. have used self tanners within the past two weeks.
  9. have excessive hair at the test site area which could, in the opinion of the investigator, interfere with the interpretation of the results.
  10. have participated in a research drug trial or patch test within six weeks of beginning this study.
  11. have a known sensitivity to Scotch 600 Transparent Tape.
  12. are currently receiving, or within the past two weeks received, topical or systemic medication which could, in the opinion of the investigator, interfere with the interpretation of the results, affect the safety of the subject, or which may change the body's response to ultraviolet light.

  13. are currently taking any of the drugs listed on the next page. In addition, the use of St. John's Wort or other similar dietary supplements, aspirin or OTC ibuprofen is for the duration of the study. Low dose daily aspirin use, 81 mgs, taken for heart attack prevention is excluded.

    • Acceptable methods of birth control that can be used during the course of the study are: oral contraceptive pill, intrauterine device, patch, injection, condom with spermicide, partner vasectomy, bilateral tubal ligation, abstinence or evidence of non (i.e., [one year without menstrual period], hysterectomy or bilateral ovariectomy).
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Interventions

  • DrugTitanium dioxide

    Topical cream

06

What researchers measure

Primary outcomes

  1. Determine degree of penetration of TiO2 down to 16 -20 tape strips of human skin

    Time frame: Single application

07

Study locations

1 site
  • Hill Top Research
    Winnipeg, Manitoba R3L2W2, Canada
08

Timeline

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

The record gives a start of Dec 2009, a primary completion of Dec 2009 and a completion of Dec 2009. 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
Nov 25, 2009
First posted
Nov 30, 2009
Start
Dec 2009
Primary completionActual
Dec 2009
CompletionActual
Dec 2009
Last update
Jun 14, 2011
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 Jun 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01021787
Lead sponsor
Loreal USA
First posted
Nov 30, 2009
Start date
Dec 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Jun 14, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Discussion

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