An interventional study of Coppertone(BAY987517) in Sunscreening Agents, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-13.
Sponsored by Bayer · Not applicable, Interventional, and Treatment
To evaluate the Sun Protection Factor (SPF) efficacy on human skin.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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
Drug: Coppertone(BAY987517)
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.
Minimal Erythema Dose(MED)
Time frame: Up to 15 minutes
Minimal Persistent Pigment Darkening Dose (MPPD)
Time frame: Up to 15 minutes
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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