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This is a 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 |
| Kirk Barber, MD | Kirk Barber Research Inc. | Principal Investigator |
| Leslie Baumann, MD | Baumann Cosmetic and Research Institute | Principal Investigator |
| Fran Cook-Bolden, MD | Skin Specialty Dermatology | Principal Investigator |
| Joseph Fowler, MD | Dermatology Specialists PSC | Principal Investigator |
| Steven Grekin, DO | Grekin Skin Institute | Principal Investigator |
| Wayne Gulliver, MD | Newlab Clinical Research Inc. | Principal Investigator |
| Robert Haber, MD | Haber Dermatology & Cosmetic Surgery | Principal Investigator |
| Michael Heffernan, MD | Central Dermatology | Principal Investigator |
| Terry Jones, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Baumann Cosmetic and Research Institute |
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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 |
|
| J&S Studies Inc. |
| Principal Investigator |
| Ian Landells, MD | Nexus Clinical Research | Principal Investigator |
| Mark Ling, MD | MedaPhase, Inc. | Principal Investigator |
| Phoebe Rich, MD | Oregon Dermatology and Research Center | Principal Investigator |
| Dow Stough, MD | Burke Pharmaceutical Research | Principal Investigator |
| William Werschler, MD | Premier Clinical Research | Principal Investigator |
| Patricia Westmoreland, MD | Palmetto Clinical Trials Services, LLC | Principal Investigator |
| Miami Beach |
| Florida |
| 33140 |
| United States |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | United States |
| Dermatology Specialists Research | Louisville | Kentucky | 40202 | United States |
| Grekin Skin Institute | Warren | Michigan | 48088 | United States |
| Central Dermatology PC | St Louis | Missouri | 63117 | United States |
| Skin Specialty Dermatology | New York | New York | 10155 | United States |
| Haber Dermatology & Cosmetic Surgery | South Euclid | Ohio | 44118 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Palmetto Clinical Trial Services, LLC | Greenville | South Carolina | 29607 | United States |
| J&S Studies Inc. | College Station | Texas | 77845 | United States |
| Premier Clinical Research | Spokane | Washington | 99201 | United States |
| Kirk Barber Research Inc. | Calgary | Alberta | T25 3B3 | Canada |
| Nexus Clinical Research | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Newlab Clinical Research Inc. | St. John's | Newfoundland and Labrador | A1C2H5 | 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 | 148 | 0 | 148 | |||
| EG001 | Placebo | 0 | 145 | 0 | 145 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations |
|
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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 |
|
| Male |
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| Canada |
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| Day 29 / Hour 9 |
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| Day 29 / Hour 12 |
|