Approximately 70 subjects (35 subjects per light and dark group) will be enrolled in this clinical study (to complete with a minimum of 10 subjects per skin type (I-VI) to assess the effects of known UV Radiation dosage on light and dark skin, assess the protective effect of two SPF test materials, placebo product, and standard sunscreen ('Pad O') on skin, before and after a known UV Radiation dosage and collect the interstitial dermal fluid from approximately 60 subjects and send to Eurofins Discovery for analysis. The following study evaluations will be obtained: SPF Determination, Visual Assessment of Erythema, Chromameter and Mexameter measurements, Digital photography, Thermometer readings and Collection of Dermal Interstitial Fluid (IDF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
60
Hybrid D II SPF 30
Chemical SPF 30
No SPF Placebo
Eurofins | CRL, Cosmetics LLC
Winston-Salem, North Carolina, United States
RECRUITINGChromameter
This study will use a reflectance colorimeter, CM-700d (Konica Minolta) or equivalent, a handheld device that measures skin color in the L\*a\*b\* color space. The L\*, a\*, and b\* values will be measured from at least 3 different locations on the subject's back and then used to calculate the ITA°, which can be used to estimate a subject's MEDu
Time frame: Chromameter measurements will be obtained at Day 1 Baseline and Day 3 post treatment
Dermal Darkening Evaluation
A technician will determine post UV dose immediate responses using the assessment scale listed below: Table 4. Immediate Response Codes N No Immediate response D Immediate Darkening R Immediate Reddening H Immediate Generalized Heat Response Spreading Beyond the Subsite
Time frame: Baseline and Day 3 Post-treatment
Erythema Dermal Evaluation
Table 5. Grading Scale for Erythema Responses to UV Doses Administered to Untreated Sites and Sunscreen-Treated Sites 0 = No erythema response or inconclusive response 0.5 = Ambiguous erythema and/or no clear border and/or not filling more than 50% of the exposure subsite. (Minimally perceptible erythema) 1. = Perceptible unambiguous erythema with clearly defined borders (filling more than 50% of the exposure subsite) 2. = Moderate to intense erythema
Time frame: Baseline and Day 3 Post-treatment
Mexameter
Three Mexameter measurements will be obtained from the subjects randomized test sites on the back at each designated time point to assess erythema and melanin.
Time frame: Baseline and Day 3 Post-treatment
Dermal interstitial fluid
Client-provided human interstitial fluid samples and commercially-sourced artificial interstitial fluid will be evaluated at multiple dilutions for levels of IL-1α, IL-6, IL-8, and VEGF-A using Luminex methodology (Thermo Fisher ProcartaPlex catalog #PPXT-04). Two (2) client-provided human interstitial fluid samples will be evaluated at 8 dilutions in singlicate.
Time frame: At the Baseline timepoint, a sub-site to the top left of the testing area will be used for the micro-needling.
Thermometer reading
A Fisher brand IR Thermometer will be used to obtain the subjects skin temperature from the following test sites: Untreated area, and for the areas treated with No SPF Placebo, Hybrid SPF 30, and Chemical Benchmark SPF 30 before and after UV Exposure.
Time frame: Right before and immediately after UV Exposure.
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