Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study

Conditions
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Acne Rosacea

Intervention / Treatment
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* Drug: Azelaic acid 15%
* Drug: Brimonidine 0.33%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female 18 years of age and older Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline Female subjects of childbearing potential must practice a reliable method of contraception throughout the study Moderate or severe rosacea with an Investigator Global Assessment (IGA) score of 3 or 4 Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization forms Exclusion Criteria: Female subjects who are pregnant, breast feeding or who are of childbearing potential and not practicing a reliable method of birthcontrol History of hypersensitivity or idiosyncratic reaction to any component of the test medications Subjects who have not completed the proper wash-out periods for prohibited medications and/or procedures Medical condition that contraindicates the subject's participation in the study Alcohol or drug abuse is evident within the past 5 years History of poor cooperation, non-compliance with medical treatment, unreliability Participation in an investigational drug study within 30 days of the Baseline visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azelaic acid 15%, Brimonidine 0.33 % Gel<br>Azelaic acid 15% to the face each AM followed 30 minutes later by Brimonidine 0.33% Azelaic acid 15% to the face each PM | Drug: Azelaic acid 15%<br>* Applied to the face each AM and PM<br>* Other names: Finacea;Drug: Brimonidine 0.33%<br>* Applied to the face each AM 30 minutes after the application of Azelaic acid 15%<br>* Other names: Miravaso;|
| Active Comparator: Brimonidine 0.33% Gel<br>Brimonidine 0.33% Gel | Drug: Brimonidine 0.33%<br>* Applied to the face each AM 30 minutes after the application of Azelaic acid 15%<br>* Other names: Miravaso;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |