Sun Protection Factor Assay
Not Applicable
Completed
- Conditions
- Sunscreening Agent
- Interventions
- Drug: Coppertone (BAY987516)
- Registration Number
- NCT02803034
- Lead Sponsor
- Bayer
- Brief Summary
To evaluate the Sun Protection Factor efficacy on human skin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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 and female
- Aged between 18-70 years old.
- Good health as determined from the HRL SHF(Self History Form)
- Signed and dated Informed Consent Form
- Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
- An unambiguous MED (Minimal Erythema Dose) 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BAY987516 Coppertone (BAY987516) 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.
- Primary Outcome Measures
Name Time Method Minimal Persistent Pigment Darkening Dose (MPPD) Up to 15 minutes Minimal Erythema Dose (MED) Up to 15 minutes
- Secondary Outcome Measures
Name Time Method