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The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, 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% QD | Experimental |
| |
| CD07805/47 Gel 0.18% QD | Experimental |
| |
| CD07805/47 Gel 0.18% BID | Experimental |
| |
| Vehicle Gel QD | Placebo Comparator |
| |
| Vehicle Gel BID | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD07805/47 Gel | Drug | CD07805/47 Gel 0.5% QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Success | Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| CEA Success | CEA success defined as 2-grade improvement on CEA. Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D, Inc | Study Director |
| William Abramovits, MD | Dermatology Treatment & Research Center | Principal Investigator |
| Fran Cook-Bolden, MD | Skin Specialty Group | Principal Investigator |
| Zoe Draelos, MD | Dermatology Consulting Services, High Point NC | Principal Investigator |
| Joseph Fowler, MD | Dermatology Specialists, PSC | Principal Investigator |
| Kimberly Grande, MD | The Skin Wellness Center | Principal Investigator |
| Michael Heffernan, MD | Central Dermatology PC | Principal Investigator |
| Steven Kempers, MD | Minnesota Clinical Study Center | Principal Investigator |
| Mark Ling, MD | Meda Phase, Inc. | Principal Investigator |
| Robert Matheson, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| University of California at San Francisco |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD07805/47 Gel 0.5% QD | CD07805/47 Gel 0.5% Once Daily |
| FG001 | CD07805/47 Gel 0.18% QD | CD07805/47 Gel 0.18% Once Daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vehicle Gel |
| Drug |
Vehicle Gel QD |
|
| CD07805/47 Gel | Drug | CD07805/47 Gel 0.18% QD |
|
| CD07805/47 Gel | Drug | CD07805/47 Gel 0.18% BID |
|
| Vehicle Gel | Drug | Vehicle Gel BID |
|
| Day 29 |
| PSA-5 Success | Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. PSA-5 success defined as 2-grade improvement on PSA-5. Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness
| day 29 |
| Oregon Medical Research |
| Principal Investigator |
| Kappa Meadows, MD | The Education & Research Foundation | Principal Investigator |
| Angela Moore, MD | Arlington Center for Dermatology | Principal Investigator |
| Girish Munavalli, MD | Dermatology, Laser & Vein Specialists of the Carolinas | Principal Investigator |
| Andrew Pollack, MD | Philadelphia Institute of Dermatology | Principal Investigator |
| Phoebe Rich, MD | Oregon Dermatology & Research Center | Principal Investigator |
| Harry Sharta, MD | Madison Skin & Research | Principal Investigator |
| Martin Steinhoff, MD | University of California at San Francisco | Principal Investigator |
| Dow Stough, MD | Burke Pharmaceutical Research | Principal Investigator |
| William Werschler, MD | Premier Clinical Research | Principal Investigator |
| Patricia Westmoreland, MD | Palmetto Clinical Trial Services, LLC | Principal Investigator |
| Stephen Schleicher, MD | DermDox | Principal Investigator |
| San Francisco |
| California |
| 94143-0660 |
| United States |
| Meda Phase, Inc | Newnan | Georgia | 30263 | United States |
| Dermatology Specialists PC | Louisville | Kentucky | 40202 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Central Dermatology, PC | St Louis | Missouri | 63117 | United States |
| Skin Specialty Group | New York | New York | 10021 | United States |
| Dermatology Laser & Vein Specialists | Charlotte | North Carolina | 28207 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Oregon Dermatology & Research Center | Portland | Oregon | 97210 | United States |
| Oregon Medical Research | Portland | Oregon | 97223 | United States |
| Philadelphia Institute of Dermatology | Fort Washington | Pennsylvania | 19034 | United States |
| DermDox | Hazleton | Pennsylvania | 18201 | United States |
| Palmetto Clinical Trial Services, LLC | Greenville | South Carolina | 29007 | United States |
| The Skin Wellness Center | Knoxville | Tennessee | 37902 | United States |
| Arlington Center for Dermatology | Arlington | Texas | 76011 | United States |
| Dermatology Treatment & Research Center | Dallas | Texas | 75230 | United States |
| The Education & Research Foundation | Lynchburg | Virginia | 24501 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| Madison Skin & Research | Madison | Wisconsin | 53719 | United States |
| FG002 | CD07805/47 Gel 0.18% BID | CD07805/47 Gel 0.18% Twice Daily |
| FG003 | Vehicle Gel QD | Vehicle Gel Once Daily |
| FG004 | Vehicle Gel BID | Vehicle Gel Twice Daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CD07805/47 Gel 0.5% QD | |
| BG001 | CD07805/47 Gel 0.18% QD | |
| BG002 | CD07805/47 Gel 0.18% BID | |
| BG003 | Vehicle Gel QD | |
| BG004 | Vehicle Gel BID | |
| BG005 | 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 |
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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 | Composite Success | Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. | Intent-to Treat (ITT) population, LOCF when the data are missing at all four timepoints (i.e. Hours 3, 6, 9, 12) LOCF method will be applied from previous visit. | Posted | Number | participants | Day 29 |
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| Secondary | CEA Success | CEA success defined as 2-grade improvement on CEA. Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
| ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit. | Posted | Number | participants | Day 29 |
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| Secondary | PSA-5 Success | Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. PSA-5 success defined as 2-grade improvement on PSA-5. Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness
| ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit. | 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 0.5% QD | 0 | 53 | 18 | 53 | |||
| EG001 | CD07805/47 Gel 0.18% QD | 1 | 54 | 13 | 54 | |||
| EG002 | CD07805/47 Gel 0.18% BID | 0 | 54 | 14 | 54 | |||
| EG003 | Vehicle Gel QD | 1 | 55 | 16 | 55 | |||
| EG004 | Vehicle Gel BID | 0 | 53 | 8 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric Reflux | Gastrointestinal disorders |
| |||
| Deep Vein Thrombosis | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Flushing | Vascular disorders |
| |||
| Intraocular pressure increased | Eye disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Skin Burning Sensation | Skin and subcutaneous tissue disorders |
| |||
| Skin Warm | Skin and subcutaneous tissue disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Sinusitis | 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Day 29/Hour 6 |
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| Day 29/Hour 9 |
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| Day 29/Hour 12 |
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Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model. |
| 0.549 |
| Odds Ratio (OR) |
| 1.269 |
| 95 |
| 0.586 |
| 2.747 |
| Superiority or Other (legacy) |
| GEE:Logit link function | Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model. | 0.027 | Odds Ratio (OR) | 3.738 | 95 | 1.097 | 12.742 | Superiority or Other (legacy) |
| Units | Counts |
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| Participants |
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| Participants |
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