Validated Claim Support (VCS)
Teaneck, New Jersey, 07666, United States
NCT Number: NCT05565625
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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Notify Me18 year–55 year
Female
Interventional
Not applicable
Teaneck, New Jersey, 07666, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will topically apply Sunscreen A at Visit 1.
Participants will apply Sunscreen B at Visit 1.
Participants will apply Sunscreen C at Visit 1.
Participants will apply Sunscreen D at Visit 1.
Participants will apply Sunscreen E at Visit 1.
Participants will apply Sunscreen F at Visit 1.
Time frame: Visit 1 (Day 1)
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.
Time frame: Visit 1 (Day 1)
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.
Time frame: Visit 1 (Day 1)
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).
Time frame: Visit 1 (Day 1)
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".
Time frame: Visit 1 (Day 1)
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*).
Time frame: Visit 1 (Day 1)
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.
Johnson & Johnson Consumer Inc. (J&JCI)
Industry
A Single-Center, Clinical Study to Evaluate the Whitening Effect of Mineral Sunscreens in Multi-Cultural Skin Tones Thru Instrumentation Measurements, Imaging, and Self-Assessments
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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