Sun Protection Factor Assay (SPF Assay 203/2016)
Study Details
Study Description
Brief Summary
To evaluate the Sun Protection Factor efficacy on human skin.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: BAY987516 Each test site area is divided into test sub site 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. |
Drug: BAY987516
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 Code:Z46-116)
|
Outcome Measures
Primary Outcome Measures
- Minimal Erythema Dose (MED) [Up to 15 minutes]
Secondary Outcome Measures
- Minimal Persistent Pigment Darkening Dose (MPPD) [Up to 15 minutes]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
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Male and female.
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Aged between 18-70 years old.
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Good health as determined from the HRL SHF (Subject History Form).
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Signed and dated Informed Consent Form.
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Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
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An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).
Exclusion Criteria:
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Subjects on test at any other research laboratory or clinic.
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Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
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Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
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Pre-existing other medical conditions (e.g. adult asthma, diabetes).
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Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
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Treatment with antibiotics within two weeks prior to initiation of the test.
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Chronic medication which could affect the results of the study.
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Known pregnant or nursing women.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Union | New Jersey | United States | 07083 |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19203