The purpose of this study is to assess how human skin reacts and how sunscreens and sun protection fabrics protect in natural sunlight compared to their labeled claims, indoor testing methods (existing or modified) and instructions.
To evaluate the difference in the level of erythema and persistent pigment darkening sun protection following a single period of natural sunlight exposure or laboratory solar simulator exposure afforded by application of sunscreens, use of fabrics, and use of pass through glass filters.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
Sunscreens of various SPF levels and ingredients
fabrics
Optical band pass or long pass filters or surfaces/mirrors used in solar simulators
Sun Protection Foundation
San Diego, California, United States
Sun Protection Foundation
Waimea, Hawaii, United States
Sun Protection Foundation
Seattle, Washington, United States
Sun Protection Foundation
Santiago, Chile
Erythema
• Erythema was assessed using a scale of 0 = no perceptible sun induced skin reaction, 1 = perceptible erythema but spotty or without clear borders (\<1 MED); 2 = minimal erythema over the entire site with distinct borders (1 MED reaction); 3 = more than minimal; 4 = a serious erythema; and 5 = edema and blisters. Determination made by blinded evaluator on-site or using chroma-meter and photographs.
Time frame: 16-24 hours post exposure to natural sunlight
Persistent Pigment Darkening (PPD)
Persistent Pigment Darkening was assessed using a scale of 0 = no perceptible sun induced skin reaction, 1 = perceptible but spotty or without clear borders (\<1 MPPDD); 2 = minimal PPD over the entire site with distinct borders (1 MPPDD reaction); 3 = more than minimal; 4 = a serious erythema; and 5 = edema and blisters Determination made by blinded evaluator on-site or using chroma-meter and photographs.
Time frame: 16-24 hours post exposure to natural sunlight
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Sun Protection Foundation
Arequipa, Peru