A Study to Evaluate the Whitening Effect of Mineral Sunscreens in Multi-Cultural Skin Tones

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sunscreen

Intervention / Treatment
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* Other: Sunscreen A
* Other: Sunscreen B
* Other: Sunscreen C
* Other: Sunscreen D
* Other: Sunscreen E
* Other: Sunscreen F


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported natural skin tone/skin color, targeting the following: skin tones Pale/fair to light white and White to light beige (n = 30 participants), skin tones Beige to light tan/light olive and Medium tan/medium olive to light brown (n = 30 participants), and Skin tones Medium brown to dark brown and darkest brown to darkest black (n = 30 participants) Has a history of using or is a current user of sunscreens Generally, in good health based on medical history reported by the participants Able to read, write, speak, and understand English Individual has signed the consent for photograph release and informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure Intends to complete the study and is willing and able to follow all study instructions Exclusion Criteria: Has known allergies or adverse reactions to common topical skincare products or ingredients in the ISMs Presents with a skin condition on the face, volar forearms, or lower legs that may confound the study results (example, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer) or interfere with evaluations (example, excessive hair, tattoos, scarring, very uneven skin tone, sunburn, scratches/broken/compromised skin) Has shaved or used any hair removal method on lower legs or volar forearms within 24 hours of Visit 1 Has a history of a confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 30 days prior to the study visit Within 14 days prior to Visit 1, has been in close contact (exposure within 6 feet for a cumulative time of 15 minutes or more over a 24-hour period) with anyone who has been infected with COVID-19 Is under a COVID-19 isolation/quarantine order Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to the study visit: unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, or chest pain/tightness; temperature greater than or equal to (>=) 37.5 degrees celsius (C)/99.5 degrees fahrenheit (F), measured; use of fever or pain reducers within 2 days prior to the study visit Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication Is taking a medication that would mask an adverse event (AE) or confound the study results, including: Immunosuppressive or steroidal drugs within 2 months before Visit 1; non-steroidal anti-inflammatory drugs within 5 days before Visit 1; antihistamines within 1 week before Visit 1 Is self-reported to be pregnant or planning to become pregnant during the study Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study Is simultaneously participating in any other clinical study or has participated in any product-use study within 14 days prior to Visit 1 Is an employee/contractor or immediate family member of the principle investigator (PI), study site, or sponsor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunscreen<br>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. | Other: Sunscreen A<br>* Participants will topically apply Sunscreen A at Visit 1.<br>Other: Sunscreen B<br>* Participants will apply Sunscreen B at Visit 1.<br>Other: Sunscreen C<br>* Participants will apply Sunscreen C at Visit 1.<br>Other: Sunscreen D<br>* Participants will apply Sunscreen D at Visit 1.<br>Other: Sunscreen E<br>* Participants will apply Sunscreen E at Visit 1.<br>Other: Sunscreen F<br>* Participants will apply Sunscreen F at Visit 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |