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

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

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.

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