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This study is designed to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirvaso Gel | Experimental | Brimonidine topical gel, 0.33% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-Treatment Clinician Erythema Assessment (CEA) | The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application. | 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Facial Redness Questionnaire | Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions) | 14 days (Day 1 (Baseline) and Day 14/Exit) |
| Subject Treatment Satisfaction Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Sugarman, MD | Redwood Dermatology Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson Dermatology | Fort Smith | Arkansas | 72916 | United States | ||
| Blue Harbor Dermatology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirvaso Gel | Brimonidine Gel (topical emulsion (gel), 0.33% brimonidine, once daily) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirvaso Gel | Brimonidine Gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Pre-Treatment Clinician Erythema Assessment (CEA) | The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application. | Intent-to-treat (ITT) Population; Subjects who received at least 1 application of study drug, and completed at least 1 assessment | Posted | Count of Participants | Participants | 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit) |
|
|
29 Days
Adverse events were recorded for at least 14 days prior to the first treatment application.
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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 Gel | Brimonidine Gel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myocardial infarction | Cardiac disorders | MedDRA version 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| condition aggravated | General disorders | MedDRA version 14.1 | Systematic Assessment |
Open label, single arm, short duration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean Philippe York | Galderma Laboratories L.P. | 817-961-5468 | jp.york@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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Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions) |
| 14 days (Day 14/Exit) |
| Facial Redness Visual Analog Scale (VAS) | The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS | 14 days (Day 1 (Baseline), Day 14/Exit) |
| Inflammatory Lesions | Change from baseline in facial inflammatory lesion count | 14 days (Day 1 (Baseline) and Day 14/Exit) |
| Newport Beach |
| California |
| 92663 |
| United States |
| Center for Dermatology and Laser Surgery | Sacramento | California | 95819 | United States |
| Redwood Dermatology Research | Santa Rosa | California | 95403 | United States |
| Florida Academic Dermatology Center | Miami | Florida | 33136 | United States |
| Research Institute of the Southeast | West Palm Beach | Florida | 33401 | United States |
| Grekin Skin Institute | Warren | Michigan | 48088 | United States |
| Advanced Skin Research Center | Omaha | Nebraska | 68144 | United States |
| Manhattan Dermatology and Cosmetic Surgery | New York | New York | 10017 | United States |
| DermDox Centers for Dermatology | Hazleton | Pennsylvania | 18201 | United States |
| Arlington Research Center | Arlington | Texas | 76011 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Subject Facial Redness Questionnaire | Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions) | ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment | Posted | Mean | Standard Deviation | Participants | 14 days (Day 1 (Baseline) and Day 14/Exit) |
|
|
|
| Secondary | Subject Treatment Satisfaction Questionnaire | Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions) | ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment | Posted | Mean | Standard Deviation | Participants | 14 days (Day 14/Exit) |
|
|
|
| Secondary | Facial Redness Visual Analog Scale (VAS) | The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS | ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment | Posted | Count of Participants | Participants | 14 days (Day 1 (Baseline), Day 14/Exit) |
|
|
|
| Secondary | Inflammatory Lesions | Change from baseline in facial inflammatory lesion count | ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment | Posted | Mean | Standard Deviation | lesions | 14 days (Day 1 (Baseline) and Day 14/Exit) |
|
|
|
| 3 |
| 181 |
| 68 |
| 181 |
| Pericarditis | Cardiac disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| feeling hot | General disorders | MedDRA version 14.1 | Systematic Assessment |
|
| rosacea | Skin and subcutaneous tissue disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 14.1 | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
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|
| Severe Erythema |
|
| Missing |
|
|
| Severe Erythema |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Not Bothered (Mean [SD], Day 14) |
|
| Bothered (Mean [SD], Day 14) |
|
| Missing (Day 14) |
|
|
| Moderate |
|
| Severe |
|
| Very Severe |
|
| Day 14 |
|
|