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Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD07805/47 gel | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD07805/47 gel | Drug | applied topically once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Success | Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA). | Day 29 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Chair |
| William Abramovits, MD | Dermatology Treatment & Research Center | Principal Investigator |
| Robert Bissonette, MD | Innovaderm Research Inc. | Principal Investigator |
| Zoe Draelos, MD | Dermatology Consulting Services, High Point NC | Principal Investigator |
| Kimberly Grande, MD | The Skin Wellness Center | Principal Investigator |
| Michael Jarratt, MD | Derm Research, PLLC | Principal Investigator |
| Charles Lynde, MD | Lynderm Research Inc | Principal Investigator |
| Robert Matheson, MD | Oregon Medical Research Center | Principal Investigator |
| Kappa Meadows, MD | The Education & Research Foundation, Inc. | Principal Investigator |
| Angela Moore, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Research Associates | Los Angeles | California | 90045 | United States | ||
| University of California, San Francisco |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD07805/47 Gel | |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
applied topically once daily |
|
| Arlington Center for Dermatology |
| Principal Investigator |
| David Nieves, MD | Windsor Dermatology | Principal Investigator |
| Andrew Pollack, MD | Philadelphia Institute of Dermatology | Principal Investigator |
| Howard Sofen, MD | Dermatology Research Associates | Principal Investigator |
| Martin Steinhoff, MD | University of California, San Francisco | Principal Investigator |
| Daniel Stewart, DO | Michigan Center for Skin Care Research | Principal Investigator |
| Jerry Tan, MD | Windsor Clinical Research Inc. | Principal Investigator |
| San Francisco |
| California |
| 94143 |
| United States |
| Michigan Center for Skin Care Research | Clinton Township | Michigan | 48038 | United States |
| Windsor Dermatology | East Windsor | New Jersey | 08520 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| Philadelphia Institute of Dermatology | Fort Washington | Pennsylvania | 19034 | United States |
| The Skin Wellness Center | Knoxville | Tennessee | 37922 | United States |
| Arlington Center for Dermatology | Arlington | Texas | 76011 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| Dermatology Treatment & Research Center | Dallas | Texas | 72230 | United States |
| The Education & Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
| Lynderm Research Inc | Markham | Ontario | L3P 1A8 | Canada |
| Windsor Clinical Research Inc. | Windsor | Ontario | N8W 5L7 | Canada |
| Innovaderm Research, Inc | Montreal | Quebec | H2K 4L5 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CD07805/47 Gel | |
| BG001 | Placebo | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Composite Success | Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA). | Intent-to-Treat (ITT) population (i.e. Hours 3,6,9,12) | Posted | Number | participants | Day 29 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CD07805/47 Gel | 1 | 129 | 0 | 129 | |||
| EG001 | Placebo | 0 | 131 | 0 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental drug intake by child | Injury, poisoning and procedural complications | Study product was accidentally ingested by two young children of a single study subject. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Graeber, MD | Galderma | 609-860-8201 | michael.graeber@galderma.com |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| >=65 years |
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| Male |
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| Canada |
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| Day 29 / Hour 9 |
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| Day 29 / Hour 12 |
|