Dermal Penetration of the Titanium Dioxide in Anthelios SX SPF40 Cream

Sunburn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021787
• Other study ID #: PEN.750.06
• Status: Completed
• Phase: Phase 4
• First received: November 25, 2009
• Last updated: June 13, 2011
• Start date: December 2009
• Est. completion date: December 2009

Study information

• Verified date: November 2009
• Source: Loreal USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Informed Consent 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:

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 birth control 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 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).

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sunburn

Intervention

Drug:
• Titanium dioxide
Topical cream

Locations

Country	Name	City	State
Canada	Hill Top Research	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Loreal USA

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine degree of penetration of TiO2 down to 16 -20 tape strips of human skin		Single application	No