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| Name | Class |
|---|---|
| Chiltern International Inc. | INDUSTRY |
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The aim of the study is to evaluate the level of satisfaction among patients to whom Mirvaso® / Onreltea TM (trade mark) is prescribed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirvaso® / Onreltea TM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirvaso® / Onreltea TM | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question | Week 4 |
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Inclusion Criteria:
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patient with persistent facial erythema of rosacea
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator site 1 | Hamilton | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirvaso® / Onreltea TM | Mirvaso® / Onreltea TM |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirvaso® / Onreltea TM | Mirvaso® / Onreltea TM |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question | Analysis was performed on total population. Here, "Overall Number of Participants Analyzed" = participants with available data for this outcome measure. | Posted | Count of Participants | Participants | Week 4 |
|
|
From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
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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 | Mirvaso® / Onreltea TM | Mirvaso® / Onreltea TM | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stéphanie Leclerc | Galderma | +33492386706 | stephanie.leclerc@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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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Duration of rosacea | Mean | Standard Deviation | Years |
|
| Previous therapies in the last 2 years | Count of Participants | Participants |
|
| Subject previously prescribed by Mirvaso | Count of Participants | Participants |
|
| Severity of facial erythema (by physician) | Count of Participants | Participants |
|
| Severity of facial erythema (by subject) | Count of Participants | Participants |
|
| Additional signs and Symptoms | Each subject can present several signs and symptoms. Here, number analyzed=participants with available data for specified categories. | Count of Participants | Participants |
|
|
| 259 |
| 1 |
| 259 |
| 61 |
| 259 |
| AORTIC ECTASIA | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| STENOSIS OF ILIACA EXTERNAL | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| RIVA STENOSIS | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
This is an agreement between the PI and sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Disclosure agreement is covered by a contract.