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A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD07805/47 Gel 0.5% | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD07805/47 gel 0.5% | Drug | In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1. | Over 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Clark, MD | Longmont Clinical PC | Principal Investigator |
| Lesly Davidson, MD | Palmetto Medical Research | Principal Investigator |
| Steven Davis, MD | Dermatology Clinical Research Center of San Antonio | Principal Investigator |
| Michael Donahue, MD | Wilmington Medical Research | Principal Investigator |
| Timothy Gardner, MD | East Tennessee Medical Research | Principal Investigator |
| Michael Gold, MD | Tennessee Clinical Research Center | Principal Investigator |
| Fasahat Hamzavi, MD | Hamzavi Dermatology | Principal Investigator |
| Mark Lee, MD | Progressive Clinicial Research, PA | Principal Investigator |
| Debra Liu, MD | Piedmont Medical Research | Principal Investigator |
| Keith Loven, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Laser Institute for Dermatology | Santa Monica | California | 90404 | United States | ||
| Cherry Creek Research, Inc |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD07805/47 Gel 0.5% | CD07805/47 Gel 0.5% once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rivergate Dermatology Clinical Research Center, PLLC |
| Principal Investigator |
| Michael Maloney, MD | Cherry Creek Research, Inc. | Principal Investigator |
| Angela Moore, MD | Arlington Center for Dermatology | Principal Investigator |
| George Murakawa, MD | Dermcenter PC - Somerset Skin Centre | Principal Investigator |
| Catherine Pointon, MD | Metrolina Medical Research | Principal Investigator |
| Elyse Rafal, MD | DermResearch Center of NewYork, Inc. | Principal Investigator |
| Stephen Schleicher, MD | DermDox | Principal Investigator |
| Joel Schlessinger, MD | Skin Specialists, PC | Principal Investigator |
| Leonard Swinyer, MD | Dermatology Research Center | Principal Investigator |
| Amanda Tauscher, MD | Compliant Clinical Research | Principal Investigator |
| Gary Waterman, MD | Deaconess Clinic | Principal Investigator |
| Jonathan Weiss, MD | Gwinnett Clinical Research Center, Inc. | Principal Investigator |
| Morrissa Baskin, MD | Wenatchee Valley Medical Center, Clinical Research Department | Principal Investigator |
| Steven Kempers, MD | Minnesota Clinical Study Center | Principal Investigator |
| Ava Shamban, MD | The Laser Institute for Dermatology | Principal Investigator |
| Harry Sharata, MD | Madison Skin & Research, Inc. | Principal Investigator |
| Russell Mader, MD | TriCities Medical Research | Principal Investigator |
| Girish Munavalli, MD | Dermatology, Laser & Vein Specialists of the Carolinas | Principal Investigator |
| Denver |
| Colorado |
| 80209 |
| United States |
| Longmont Clinical PC | Longmont | Colorado | 80501 | United States |
| Gwinnett Clinical Research Center, Inc | Snellville | Georgia | 30078 | United States |
| Deaconess Clinic | Evansville | Indiana | 47713 | United States |
| Compliant Clinical Research | Olathe | Kansas | 66061 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Dermcenter PC- Somerset Skin Centre | Troy | Michigan | 48084 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| DermResearch Center of New York, Inc | Stony Brook | New York | 11790 | United States |
| Metrolina Medical Research | Charlotte | North Carolina | 27277 | United States |
| Dermatology, Laser & Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| Wilmington Medical Research | Wilmington | North Carolina | 28401 | United States |
| Piedmont Medical Research | Winston-Salem | North Carolina | 27103 | United States |
| DermDox | Hazleton | Pennsylvania | 18201 | United States |
| Palmetto Medical Research | Mt. Pleasant | South Carolina | 29464 | United States |
| Rivergate Dermatology Clinical Research Center, PLLC | Goodlettsville | Tennessee | 37072 | United States |
| East Tennessee Medical Research | Johnson City | Tennessee | 37604 | United States |
| TriCities Medical Research | Kingsport | Tennessee | 37660 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Arlington Center for Dermatology | Arlington | Texas | 76011 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Progressive Clinical Research, PA | San Antonio | Texas | 78229 | United States |
| Dermatology Research Center | Salt Lake City | Utah | 84124 | United States |
| Wenatchee Valley Medical Center - Clinical Research Department | Wenatchee | Washington | 98801 | United States |
| Madison Skin & Research, Inc. | Madison | Wisconsin | 53719 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CD07805/47 Gel 0.5% | CD07805/47 Gel 0.5% once daily |
| 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 |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea. | Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1. | Posted | Mean | Standard Deviation | scores on a scale | Over 1 year |
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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 0.5% | 12 | 449 | 101 | 449 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess tooth w/ secondary submandibular infection | Infections and infestations |
| |||
| Osteoarthritis of left hip | Musculoskeletal and connective tissue disorders |
| |||
| Advanced squamous cell carcinoma of the lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| COPD | Respiratory, thoracic and mediastinal disorders |
| |||
| Encephalopathy | Nervous system disorders |
| |||
| Invasive ductal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Distal Esophageal Schatzki's Ring | Gastrointestinal disorders |
| |||
| Unstable Angina | Cardiac disorders |
| |||
| Right Ovarian Cyst | Reproductive system and breast disorders |
| |||
| Sustained Ventricular Tachycardia | Cardiac disorders |
| |||
| Atypical Pneumonia | Infections and infestations |
| |||
| Sepsis | Infections and infestations |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Synovitis Right Ankle | Musculoskeletal and connective tissue disorders |
| |||
| Persistent Abnormal Uterine Bleeding | Reproductive system and breast disorders |
| |||
| Bilateral Achilles Tendon ruptures | Injury, poisoning and procedural complications |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders |
| |||
| Rosacea | Skin and subcutaneous tissue disorders |
| |||
| Flushing | Vascular disorders |
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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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| Title | Measurements |
|---|---|
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| Month 3 / Hour 3 |
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| Month 6 / Hour 3 |
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| Month 9 / Hour 3 |
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| Month 12 / Hour 3 |
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