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| ID | Type | Description | Link |
|---|---|---|---|
| CCSSKA004479 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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The purpose of this study is to evaluate the whitening potential effect of different mineral sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment and also evaluate the relationship between self-perception and objective measurement of whitening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunscreen | Experimental | Participants will receive two of six sunscreens (A, B, C, D, E, and F) at Visit 1 (Day 1) to apply to whole lower legs (1 sunscreen per lower leg), between the knee and ankle. Participant will then select one of the two sunscreens randomly assigned to lower legs and apply the selected sunscreen to full face. After lower legs and facial applications are completed, a trained designee will delineate six 4 centimeters (cm)*4 cm test sites on the participants' volar forearms (3 test sites per volar forearm). The six sunscreens will be randomly assigned to the six test sites at a dose of 2.00 +- 0.05 milligrams per centimeter square (mg/cm^2) using a 1cc tuberculin syringe (without a needle) and a clean finger cot for approximately 20 to 50 seconds and applied by a trained designee. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen A | Other | Participants will topically apply Sunscreen A at Visit 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Instrumentation | Whitening potential of mineral sunscreens across multi-cultural skin tones through instrumentation (SkinSkan measurements) will be reported. SkinSkan is a non-invasive diagnostic tool that uses an optical fiber probe to collect the fluorescence signal from skin after excitation light is delivered through the same fiber probe. | Visit 1 (Day 1) |
| Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Imaging | Whitening potential of mineral sunscreens across multi-cultural skin tones through imaging (facial and vocal forearms) will be reported. Image analysis will be done by using the Matlab software. A small region of interest (ROI) will be defined on the gray standard, and five regions on the face (forehead, nose, chin, left cheek, and right cheek) and the test regions on the volar forearms. The average RGB (red, green, and blue) values from these ROI will be extracted from the images. The RGB values from the gray standard will be used to calculate the correction factors per image based on the gray standard's target RGB values. Matlab will be used to convert the corrected RGB values to the LAB values. Skin whitening defined as the change in L* values pre and post product application. L* value is defined as lightness in LAB color space. High L* value corresponds to whiter color while low L* value corresponds to blacker color. | Visit 1 (Day 1) |
| Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Self-assessment | Whitening potential of mineral sunscreens across multi-cultural skin tones through self-assessment will be reported via self-assessment questionnaire (Part B). This questionnaire rank whitening potential after application of the sunscreen product to the designated test areas on both inner forearms in order of least whitening (1) to most whitening (6). | Visit 1 (Day 1) |
| Relationship Between Self-assessment and Instrumentation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Usage Versus Whitening Effect from a Sunscreen | Whitening effect from a sunscreen that impacts participant application behavior and ultimately their sun protection will be reported. This is being determined by correlation of the self-application dosage (milligrams per centimeter square [mg/cm^2]) per treatment area versus measured whitening effect (delta L*). | Visit 1 (Day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Wrone, M.D., FAAD | Validated Claim Support (VCS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Validated Claim Support (VCS) | Teaneck | New Jersey | 07666 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3377516 | Background | Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available. | |
| Background | U.S. Census Bureau. (n.d.). About race. Retrieved July 27, 2021, from https://www.census.gov/topics/population/race/about.html | ||
| Background | U.S. Census Bureau. (n.d.). About the Hispanic population and its origin. Retrieved July 27, 2021, from https://www.census.gov/topics/population/hispanic-origin/about.html | ||
| 7312955 |
| Label | URL |
|---|---|
| Redacted CSR Synopsis | View source |
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Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| Sunscreen B |
| Other |
Participants will apply Sunscreen B at Visit 1. |
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| Sunscreen C | Other | Participants will apply Sunscreen C at Visit 1. |
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| Sunscreen D | Other | Participants will apply Sunscreen D at Visit 1. |
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| Sunscreen E | Other | Participants will apply Sunscreen E at Visit 1. |
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| Sunscreen F | Other | Participants will apply Sunscreen F at Visit 1. |
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Relationship between self-assessment and instrumentation (sunscreen product) will be reported via self-assessment questionnaire (Part A) which include the question about 'how much did you like or dislike the appearance of the sunscreen product on your skin' rated on a 5-point likert scale where 1 indicates "disliked it very much", 2 indicates "disliked it somewhat", 3 indicates "neither liked or disliked it", 4 indicates "liked it somewhat" and 5 indicates "liked it very much".
| Visit 1 (Day 1) |
| Skin Reflectance Before and After Sunscreen Applications as Assessed by SkinSkan Instrument | Skin reflectance will be assessed by SkinSkan instrument. SkinSkan instrument is a non-invasive diagnostic tool that uses an optical fiber probe to collect the signal from skin after excitation light is delivered through the same fiber probe. The spectra acquired at post sunscreen application and baseline for each site will be used to calculate Sun Protection Factor (SPF) following published Hybrid Diffuse Reflectance Spectroscopy (HDRS) method. Four replicates of spectra will be averaged to produce mean intensity of reflectance at baseline and sunscreen covered skin. Thus, each site measurement will produce one SPF level. | Visit 1 (Day 1) |
| Background |
| Wan S, Anderson RR, Parrish JA. Analytical modeling for the optical properties of the skin with in vitro and in vivo applications. Photochem Photobiol. 1981 Oct;34(4):493-9. doi: 10.1111/j.1751-1097.1981.tb09391.x. |
| Background | Mark Ruzon (2021). RGB2Lab (https://www.mathworks.com/matlabcentral/fileexchange/24009-rgb2lab), MATLAB Central File Exchange. Retrieved November 29, 2021. |
| 3657876 | Background | Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987 Oct 22;317(17):1098. doi: 10.1056/NEJM198710223171717. No abstract available. |
| 31795625 | Background | Murari A, Singh KN. Lund and Browder chart-modified versus original: a comparative study. Acute Crit Care. 2019 Nov;34(4):276-281. doi: 10.4266/acc.2019.00647. Epub 2019 Nov 29. |