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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Location | Other | Location and Intensity of Exposure to Sunlight otc sunscreens sun protection fabrics optical filters |
|
| Single Duration or SPF Test | Other | Single exposure of interventions or multiple exposures of interventions (SPF or PPD-PF tests) otc sunscreens sun protection fabrics optical filters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| otc sunscreens | Drug | Sunscreens of various SPF levels and ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 16-24 hours post exposure to natural sunlight |
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Inclusion Criteria:
Fitzpatrick Type I, II, III, IV or V type skin.
Must be able to be exposed to natural sunlight for up to 4 hours in a prone position
Able to read, write, speak and understand the English language.
Has personally read, signed, and dated the Informed Consent Form (including HIPAA disclosure) and Photograph Release
Generally in good health based on medical history reported by the subject
Healthy male or female subjects with no history or evidence of clinically relevant medical disorder, as determined from a brief medical history interview.
Willing and able to follow the study instructions, including:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaun Hughes, MBA | Sun Protection Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Protection Foundation | San Diego | California | 98108 | United States | ||
| Sun Protection Foundation |
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| sun protection fabrics | Other | fabrics |
|
|
| Optical Filters | Other | Optical band pass or long pass filters or surfaces/mirrors used in solar simulators |
|
|
| Waimea |
| Hawaii |
| 98108 |
| United States |
| Sun Protection Foundation | Seattle | Washington | 98108 | United States |
| Sun Protection Foundation | Santiago | Chile |
| Sun Protection Foundation | Arequipa | Peru |
| ID | Term |
|---|---|
| D013471 | Sunburn |
| D004890 | Erythema |
| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002056 | Burns |
| D014947 | Wounds and Injuries |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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