SunburnPhase 4NCT01021787
Dermal Penetration of the Titanium Dioxide in Anthelios SX SPF40 Cream
A Phase 4 study testing Titanium dioxide in people with Sunburn, run by Loreal USA at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunburn
- What is being tested?
- Titanium dioxide
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to Dec 2009
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects must:
- be between the ages of 18 and 65.
- agree to not participate in any other product evaluations or clinical evaluations during the course of this study.
- have read, understood and signed an Informed Consent Form.
- have intact skin in the treatment area.
- have fair skin - Skin Types I, or II - as defined in Appendix II.
- be able to understand and willing to follow all study procedures and restrictions.
Who cannot join
- Subjects will be excluded from participating in the study if they:
- are female and are pregnant or lactating [must be using an acceptable method of birth control if of child bearing potential].*
- 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.
- have a history of allergic responses to sunscreens or other products similar to those included in this study.
- have very dry or scaly skin on the test site.
- have diabetes.
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- have a history of abnormal responses to sunlight, such as a phototoxic or photoallergic response.
- have an existing sunburn or suntan, or been to a tanning booth which would interfere with interpretation of the study results.
- have used self tanners within the past two weeks.
- have excessive hair at the test site area which could, in the opinion of the investigator, interfere with the interpretation of the results.
- have participated in a research drug trial or patch test within six weeks of beginning this study.
- have a known sensitivity to Scotch 600 Transparent Tape.
- 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.
- 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 contraindicated 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 childbearing potential (i.e., post-menopausal [one year without menstrual period], hysterectomy or bilateral ovariectomy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dermal Penetration of the Titanium Dioxide in Anthelios SX SPF 40 Sunscreen Cream With Micronized TiO2 and Anthelios SX SPF 40 Cream (With Pigmentary TiO2) Into the Stratum Corneum of Compromised (Induced Sunburn) Human Skin
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.
- Conditions
- Sunburn
- Being tested
- Titanium dioxide
- Keywords
- Sun Protection
- Medical subject headings
- Sunburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium dioxideDrug
Topical cream
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine degree of penetration of TiO2 down to 16 -20 tape strips of human skin
Measured: Single application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2009
- Study completionDec 2009
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 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loreal USA
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021787
- Sponsor's protocol ID
- PEN.750.06
- Status last verified
- Nov 2009
- First submitted
- 25 Nov 2009
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermal Penetration of the Titanium Dioxide in Anthelios SX SPF 40 Sunscreen Cream With Micronized TiO2 and Anthelios SX SPF 40 Cream (With Pigmentary TiO2) Into the Stratum Corneum of Compromised (Induced Sunburn) Human Skin
- ClinicalTrials.gov ID
- NCT01021787
- Acronym / sponsor ID
- PEN.750.06
- Conditions
- Sunburn
- Keywords
- Sun Protection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Loreal USAIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Nov 2009 (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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All subjects must:
Key exclusion criteria (15 listed)
- are female and are pregnant or lactating [must be using an acceptable method of birth control if of child bearing potential].*
- 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.
- have a history of allergic responses to sunscreens or other products similar to those included in this study.
- have very dry or scaly skin on the test site.
- have diabetes.
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 |
|---|---|---|
| Titanium dioxideTopical cream | Drug | – |
Primary outcome
Determine degree of penetration of TiO2 down to 16 -20 tape strips of human skin
Time frame: Single application
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 14 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.
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 4 study testing Titanium dioxide in people with Sunburn, run by Loreal USA at 1 site in Canada.
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 7 inclusion and 15 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 14 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 Canada. 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 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?
Determine degree of penetration of TiO2 down to 16 -20 tape strips of human skin (time frame: Single application). 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 14 Jun 2011.