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The objective of this study is to assess the level of pigmentation following an acute exposure of skin to light regimens representative of portions of the natural sunlight spectrum and that contain Deep UVA wavelengths with or without HEV Blue Light, as compared to non-irradiated control skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen 1: Deep UVA | Experimental | Deep UVA, 380-400nm, will be used for subsites 2 to 7 of Test Sites 1 and 2. |
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| Regimen 2: Deep UVA + HEV Blue Light | Experimental | Deep UVA + HEV Blue Light, 380-420 nm, will be used for subsites 2 to 7 of Test Sites 3 and 4 |
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| Non-irradiated control | No Intervention | Subsite 1 in each test site (Test Sites 1-4) will be a non-irradiated control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep UVA Irradiation | Other | A timed series of 6 UV doses will be administered to subsites 2 to 7 within Test Site 1 and 2 using an accurately calibrated solar simulator by varying the irradiation intensity for each subsite and keeping the duration of irradiation constant for all subsites. The duration of irradiation for each test site will be 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Pigmentation level as determined by clinical evaluation | The subsites of each test site will be graded for immediate or persistent pigmentation darkening (IPD/PPD) by a trained evaluator using a 0-2 grading scale, where 0 = no pigmentation darkening and 2 = moderate to intense pigmentation darkening.The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2. | 15 mins and 18-22 hours Post-Irradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Pigmentation response as quantified by imaging | Images of each test site will be analyzed to quantify the level of pigmentation using L* and b* color space values, where an increase in pigmentation corresponds to a decrease in L* values and a potential decrease in b* values or increase in a* values. Change from baseline will be calculated. The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Union Research Center, a Division of SGS North America, Inc. | Union City | New Jersey | 07083 | United States |
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| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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4 test sites will be defined on the subjects' backs. Each test site will contain 7 subsites
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| Deep UVA+HEV Blue Light Irradiation | Other | A timed series of 6 UV doses will be administered to subsites 2 to 7 within Test Site 3 and 4 using an accurately calibrated solar simulator by varying the irradiation intensity for each subsite and keeping the duration of irradiation constant for all subsites. The duration of irradiation for each test site will be 30 minutes. |
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| Baseline, 15 mins and 18-22 hours Post-Irradiation |
| Pigmentation response as quantified by Chromameter | A Chromameter will be used to quantify the level of pigmentation of subsites 1 and 7 using L* and b* color space values, where an increase in pigmentation corresponds to a decrease in L* values and a potential decrease in b* values or increase in a* values. Change from baseline will be calculated. The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2. | Baseline, 15 mins and 18-22 hours Post-Irradiation |