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The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream | Experimental | Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks. Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks. |
|
| CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream | Placebo Comparator | Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine 0.33% gel (Br) | Drug |
| ||
| CD07805/47 (Br) placebo gel |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA): | Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1) | week 12/Hour 3 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Smith | Arkansas | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream | Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks. Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks. Brimonidine 0.33% gel (Br) CD07805/47 (Br) placebo gel Ivermectin 1% cream (IVM) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Other |
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| Ivermectin 1% cream (IVM) | Drug |
|
| CD5024 (IVM) placebo cream | Other |
|
| Rogers |
| Arkansas |
| United States |
| Sacramento | California | United States |
| Orlando | Florida | United States |
| Omaha | Nebraska | United States |
| New York | New York | United States |
| Pflugerville | Texas | United States |
| Surrey | British Columbia | Canada |
| Markham | Ontario | Canada |
| Peterborough | Ontario | Canada |
| Richmond Hill | Ontario | Canada |
| Waterloo | Ontario | Canada |
| Windsor | Ontario | Canada |
| FG001 | CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream | Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks. CD07805/47 (Br) placebo gel CD5024 (IVM) placebo cream |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream | Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks. Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks. Brimonidine 0.33% gel (Br) CD07805/47 (Br) placebo gel Ivermectin 1% cream (IVM) |
| BG001 | CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream | Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks. CD07805/47 (Br) placebo gel CD5024 (IVM) placebo cream |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA): | Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1) | Intent To Treat (ITT) Population | Posted | Count of Participants | Participants | week 12/Hour 3 |
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All AEs occurring after subject's consent and during the study were recorded; 3 months for a given subject 10 months for the study; ie: from first subject enrolled until last visit of last subject enrolled
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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 | Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream | Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks. Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks. Brimonidine 0.33% gel (Br) CD07805/47 (Br) placebo gel Ivermectin 1% cream (IVM) | 0 | 95 | 5 | 95 | 8 | 95 |
| EG001 | CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream | Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks. CD07805/47 (Br) placebo gel CD5024 (IVM) placebo cream | 0 | 95 | 1 | 95 | 13 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Biliary cirrhosis primary | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| rosacea | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fabien AUDIBERT, Sr CPM | GALDERMA | +33 (0) 4 9238 3034 | fabien.audibert@galderma.com |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D005782 | Gels |
| D007559 | Ivermectin |
| D000069416 | Intravital Microscopy |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Male |
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