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| Name | Class |
|---|---|
| Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma | INDUSTRY |
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The pilot study will investigate whether combination treatment of Finacea 15% Gel and Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in treating both the papules/pustules and erythema associated with rosacea.
Acne rosacea is a chronic inflammatory disease with different components including inflammatory lesions (papules/pustules), erythema and telangiectasia. Brimonidine 0.33% Gel primarily affects the erythematous components of rosacea. As such, combination treatment with a standard rosacea treatment, such as Finacea 15% Gel, may provide additional relief for the inflammatory component of rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azelaic acid 15%, Brimonidine 0.33 % Gel | Experimental | Azelaic acid 15% to the face each AM followed 30 minutes later by Brimonidine 0.33% Azelaic acid 15% to the face each PM |
|
| Brimonidine 0.33% Gel | Active Comparator | Brimonidine 0.33% Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelaic acid 15% | Drug | Applied to the face each AM and PM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) at Baseline | Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe | Baseline |
| IGA | Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe | Week 4 |
| IGA | Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe | Week 8 |
| IGA | Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Counts | The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line | Baseline |
| Clinician's Erythema Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon H. Kircik, M.D. | DermResearch, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
Subjects could be excluded if less than 18 years of age, who does not have moderate to severe rosacea as determined by the Investigator Global Assessment (IGA), who has not completed the specified washout for medications as outlined in the protocol or who has been in another investigational study within 30 days of the Baseline visit.
Single site recruitment, private medical clinic.. Subjects 18 to 85 years of age with moderate to severe rosacea.Recruitment began May 2014 and ended November 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 0.33 % Gel | Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33% |
| FG001 | Brimonidine 0.33% Gel | Brimonidine 0.33% Gel applied to the face each morning Brimonidine 0.33% |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
subjects between 18 years and 85 years of age with moderate to severe rosacea
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| ID | Title | Description |
|---|---|---|
| BG000 | Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33% |
| BG001 |
| 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 | Investigator Global Assessment (IGA) at Baseline | Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe | Only participants who were not lost to follow up or did not withdraw consent were included in the final analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
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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 | Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel | Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face Finacea 15 % Gel (azelaic acid 15%) each evening to the face Azelaic acid 15% Brimonidine 0.33% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulled muscle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | right hip |
Pilot study. Small number of participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leon H. Kircik, M.D. | DermResearch, PLLC | 502-451-9000 | wedoderm@yahoo.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 |
|---|---|
| C010038 | azelaic acid |
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| Brimonidine 0.33% | Drug | Applied to the face each AM 30 minutes after the application of Azelaic acid 15% |
|
|
Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured.
| Baseline |
| Erythema Visual Analog Scale (VAS) Assessment (Subject) | Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable) | Baseline |
| Dermatology Life Quality Index (DLQI) | The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible. | Baseline |
| Lesion Count | Week 4 |
| Lesion Counts | Week 8 |
| Lesion Counts | Week 12 |
| Erythema | Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red | Week 4 |
| Erythema | Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red | Week 8 |
| Erythema | Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red | Week 12 |
| Visual Analog Scale (VAS) | participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable | Week 4 |
| VAS | participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable | Week 8 |
| VAS | participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable | Week 12 |
| Dermatology Life Quality Index (DLQI) | Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) | Week 4 |
| DLQI | Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) | Week 8 |
| DLQI | Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) | Week 12 |
| Lost to Follow-up |
|
| Brimonidine 0.33% Gel |
Brimonidine 0.33% Gel applied to the face each morning Brimonidine 0.33% |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Brimonidine 0.33% Gel applied to the face each morning
Brimonidone 0.33%
|
|
| Secondary | Lesion Counts | The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line | Posted | Mean | Standard Deviation | lesions | Baseline |
|
|
|
| Secondary | Clinician's Erythema Assessment | Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Erythema Visual Analog Scale (VAS) Assessment (Subject) | Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Dermatology Life Quality Index (DLQI) | The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | IGA | Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
|
|
| Primary | IGA | Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
|
|
|
| Primary | IGA | Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | Lesion Count | Posted | Mean | Standard Deviation | lesions | Week 4 |
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| Secondary | Lesion Counts | Posted | Mean | Standard Deviation | lesions | Week 8 |
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| Secondary | Lesion Counts | Posted | Mean | Standard Deviation | lesions | Week 12 |
|
|
|
| Secondary | Erythema | Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
|
|
| Secondary | Erythema | Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
|
|
|
| Secondary | Erythema | Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
| Secondary | Visual Analog Scale (VAS) | participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
|
|
| Secondary | VAS | participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
|
|
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| Secondary | VAS | participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
| Secondary | Dermatology Life Quality Index (DLQI) | Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
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| Secondary | DLQI | Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
|
|
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| Secondary | DLQI | Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Brimonidine 0.33% Gel | Brimonidine 0.33% Gel applied to the face each morning Brimonidone 0.33% | 0 | 12 | 4 | 12 |
|
| Broken toe | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Left fourth toe |
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| worsening erythema on face | Skin and subcutaneous tissue disorders | Non-systematic Assessment | treatment area |
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| worsening facial lesions | Skin and subcutaneous tissue disorders | Non-systematic Assessment | treatment area |
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| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| common cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| sinus infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| herpes simplex | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Adjacent to treatment area |
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| burning at application site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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