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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Derm Research, PLLC
• Collaborator: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
• Treatments: Azelaic acid; Brimonidine Tartrate

Criteria

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