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The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of rosacea when applied twice daily for 6 weeks.
This is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with rosacea and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.
Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs.
Preliminary efficacy will be assessed through inflammatory lesion counts, the Investigator's Global Evaluation (IGE) and the Rosacea Signs and Symptoms (RSS) scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRM02 | Experimental | DRM02 Topical Gel, 0.25% |
|
| Vehicle | Placebo Comparator | DRM02 Topical Gel, Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRM02 | Drug |
| ||
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory lesion count | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Evaluation (IGE) | From baseline to weeks 0, 1, 2, 3, 4 and 6 | |
| IGE dichotomized into "success" and "failure" | Week 6 | |
| Percent change in inflammatory lesions |
| Measure | Description | Time Frame |
|---|---|---|
| Rosacea Signs and Symptoms (RSS) | From baseline to weeks 0, 1, 2, 3, 4 and 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Zib | Dermira, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Windsor Clinical Research, Inc. | Windsor | Ontario | N8W 5W7 | Canada | ||
| Clinique Médicale Dr Isabelle Delorme |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| Week 6 |
| Drummondville |
| Quebec |
| J2B5L4 |
| Canada |
| Innovaderm Research, Inc | Montreal | Quebec | H2K 4L5 | Canada |