An interventional study of otc sunscreens and sun protection fabrics in Sunburn, Sun Damaged Skin and Overexposure to Sun Rays, sponsored by Sun Protection Foundation. Enrolling by invitation at 5 sites in 3 countries. Open to participants aged 15 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Sun Protection Foundation · Not applicable, Interventional, and Prevention
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.
Willing and able to follow the study instructions, including:
Exclusion Criteria:
Location and Intensity of Exposure to Sunlight otc sunscreens sun protection fabrics optical filters
Drug: otc sunscreens · Other: sun protection fabrics · Other: Optical Filters
Single exposure of interventions or multiple exposures of interventions (SPF or PPD-PF tests) otc sunscreens sun protection fabrics optical filters
Drug: otc sunscreens · Other: sun protection fabrics · Other: Optical Filters
Sunscreens of various SPF levels and ingredients
Also known as: 30 SPF Broad Spectrum Sunscreen, 40 SPF Broad Spectrum Sunscreen, 45 SPF Broad Spectrum Sunscreen, 50 SPF Broad Spectrum Sunscreen, 60 SPF Broad Spectrum Sunscreen, 100 SPF Broad Spectrum Sunscreen, 110 SPF Broad Spectrum Sunscreen, Sunscreen Standard P2 15 SPF, Sunscreen Standard S2 12 UVA-PF, Sunscreen Standard P1 4 SPF, 70 SPF Broad Spectrum Sunscreen, 85 SPF Broad Spectrum Sunscreen, Reference Standard Sunscreens at various SPF levels
fabrics
Also known as: 100+ SPF Broad Spectrum Fabric Solumbra, 30+ SPF Broad Spectrum Fabric Solumbra
Optical band pass or long pass filters or surfaces/mirrors used in solar simulators
Also known as: Pass Through Glass
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
Plan to share: No
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