Dermal Penetration of the Titanium Dioxide in Anthelios SX SPF40 Cream

This study has been completed.
Sponsor:
Information provided by:
Loreal USA
ClinicalTrials.gov Identifier:
NCT01021787
First received: November 25, 2009
Last updated: June 13, 2011
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Sunburn
Drug: Titanium dioxide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Loreal USA:

Primary Outcome Measures:
  • Determine degree of penetration of TiO2 down to 16 -20 tape strips of human skin [ Time Frame: Single application ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: December 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Titanium dioxide
    Topical cream
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021787

Locations
Canada, Manitoba
Hill Top Research
Winnipeg, Manitoba, Canada, R3L2W2
Sponsors and Collaborators
Loreal USA
  More Information

No publications provided

Responsible Party: Jean Grieve, Assistant Vice President, L'Oreal USA Products Inc.
ClinicalTrials.gov Identifier: NCT01021787     History of Changes
Other Study ID Numbers: PEN.750.06
Study First Received: November 25, 2009
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Loreal USA:
Sun Protection

Additional relevant MeSH terms:
Sunburn
Photosensitivity Disorders
Skin Diseases
Burns
Wounds and Injuries
Titanium dioxide
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Photosensitizing Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 28, 2014