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

Phase 4

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Azelaic acid 15%, Brimonidine 0.33 % Gel	Brimonidine 0.33%	Azelaic acid 15% to the face each AM followed 30 minutes later by Brimonidine 0.33% Azelaic acid 15% to the face each PM
Azelaic acid 15%, Brimonidine 0.33 % Gel	Azelaic acid 15%	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	Brimonidine 0.33%	Brimonidine 0.33% Gel

Primary Outcome Measures

Name	Time	Method
Investigator Global Assessment (IGA) at Baseline	Baseline	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
IGA	Week 12	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	Week 4	participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Lesion Count	Week 4
Erythema	Week 12	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
VAS	Week 12	participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Lesion Counts	Week 12
Erythema Visual Analog Scale (VAS) Assessment (Subject)	Baseline	Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)
Dermatology Life Quality Index (DLQI)	Week 4	Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
DLQI	Week 12	Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
Clinician's Erythema Assessment	Baseline	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.