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To evaluate the Sun Protection Factor (SPF) efficacy on human skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY 987517 | Experimental | Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coppertone(BAY987517) | Drug | Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.Formulation number - SR16-02. |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Erythema Dose(MED) | Up to 15 minutes | |
| Minimal Persistent Pigment Darkening Dose (MPPD) | Up to 15 minutes |
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Inclusion Criteria: - Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. - Male or female - Aged between 18-70 years old. - Good health - Signed and dated Informed Consent Form - Signed and dated Health Insurance Portability and Accountability Authorization (HIPAA) Form - An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: - Subjects on test at any other research laboratory or clinic. - Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. - PRe-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. - Pre-existing other medical conditions (e.g. adult asthma. diabetes). - Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. - Treatment with antibiotics within two weeks prior to initiation of the test - Chronic medication which could affect the results of the study. - Known pregnant or nursing women.
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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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