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Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPF evaluation + Control | Experimental | Fair-skinned subjects in good health with Skin Types I, II or III. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY987516 | Drug | 2.00 mg/cm2 ± 0.04 mg/cm2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sun Protection Factor (SPF) efficacy on the skin of human subjects before a total of 2 hours of water Immersion | The subsites on each of the protected test sites [test sunscreen and/or Control] shall be exposed to UV light. The value of each subsite exposure shall be as appropriate to the test Method: the subject's Minimal Erythema Dose (MED) or MPPD Minimal Persistent Pigment Darkening Dose (MPPD) multiplied by the specific time intervals required. The unprotected skin site is divided into five subsites and shall also be exposed to UV light. The time intervals selected are a geometric series represented by (1.25)n, (n = the subjects MED or MPPD, at the middle [3"'] subsite) wherein each exposure time interval is 25 percent greater than the previous time or intensity. The SPF of each TM for each subject is then calculated from the exposure time interval required to produce the MED or MPPD of the protected skin, and from the exposure time interval required to produce the MED or MPPD of the unprotected skin. | up to 24 hours post-exposure |
| Sun Protection Factor (SPF) efficacy on the skin of human subjects after a total of 2 hours of water Immersion | The subsites on each of the protected test sites [test sunscreen and/or Control] shall be exposed to UV light. The value of each subsite exposure shall be as appropriate to the test Method: the subject's Minimal Erythema Dose (MED) or MPPD Minimal Persistent Pigment Darkening Dose (MPPD) multiplied by the specific time intervals required. The unprotected skin site is divided into five subsites and shall also be exposed to UV light. The time intervals selected are a geometric series represented by (1.25)n, (n = the subjects MED or MPPD, at the middle [3"'] subsite) wherein each exposure time interval is 25 percent greater than the previous time or intensity. The SPF of each TM for each subject is then calculated from the exposure time interval required to produce the MED or MPPD of the protected skin, and from the exposure time interval required to produce the MED or MPPD of the unprotected skin. | up to 24 hours post-exposure |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union | New Jersey | 07083 | United States |
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| SPF 15 Control |
| Drug |
2.00 mg/cm2 ± 0.04 mg/cm2 |
|