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To determine the phototoxic potential of a topically applied article in human subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | All subjects are patched. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen Sport Lotion (BAY987516) | Drug | 50 μl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB# Y65-110) |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of skin reactions will be evaluated using the 5 point grading scale | Up to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piscataway | New Jersey | 08854 | United States |
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| Untreated Skin | Other | This site is patched without treatment as irradiated control |
|