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The purpose of this study is to evaluate if the test sunscreen skin care product will be well-tolerated and help facial redness when applied to the face after 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunscreen Lotion | Experimental | Subjects with rosacea will apply the test sunscreen lotion to the face for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coppertone, BAY1183345 | Drug | Lotion, for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects exhibiting increases in papules | Up to 4 weeks | |
| Number of subjects exhibiting increases in erythema | Up to 4 weeks | |
| Number of subjects exhibiting increases in dryness, telangiectasia and tactile surface roughness | Up to 4 weeks | |
| Number of subjects exhibiting increases in any subjective irritation | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in facial redness measured by spectrophotometer | From baseline up to 4 weeks | |
| Change in facial redness measured by digital imaging | From baseline up to 4 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Education & Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Percentages for each response to hedonic questionnaire assessing product experience |
| Up to 4 weeks |