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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 Placebo | Placebo Comparator | Placebo |
|
| CD07805/47 gel | Experimental | Intervention: Drug: CD07805/47 gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: CD07805/47 gel | Drug |
| ||
| CD07805/47 gel Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA). | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | 30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes. | D1 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site | Montpellier | 34 | France | |||
| Galderma Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD07805/47 Gel Placebo | Placebo Drug: CD07805/47 gel |
| FG001 | CD07805/47 Gel | Intervention: Drug: CD07805/47 gel CD07805/47 gel Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CD07805/47 Gel Placebo | Placebo Drug: CD07805/47 gel |
| BG001 | CD07805/47 Gel | Intervention: Drug: CD07805/47 gel CD07805/47 gel Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | 30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes. | Not Posted | D1 | ||||||||||||
| Primary | Composite Success Assessment (CEA) and Patient Self Assessment(PSA). | Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA). | 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 Placebo | Placebo Drug: CD07805/47 gel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angiodema | Skin and subcutaneous tissue disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galderma CPM | Galderma R&D | 00 33 4 93 95 70 70 | clinicaltrials@galderma.com |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| Nice |
| 06 |
| France |
| Galderma Investigational Site | Chelyabinsk | Russia |
| Galderma Investigational Site | Moscow | Russia |
| Galderma Investigational Site | Saint Petersburg | Russia |
| Galderma Investigational Site | Yekaterinburg | Russia |
| Galderma Investigational Site | Eskilstuna | Sweden |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | CD07805/47 Gel | Intervention: Drug: CD07805/47 gel CD07805/47 gel Placebo | 1 | 57 | 10 | 57 |
| Rosacea | Skin and subcutaneous tissue disorders |
|
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