Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea

Exclusion Criteria

• •1. Patients with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses similar to rosacea, such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia, that are present on the face (i.e., 5 areas: chin, nose, both cheeks, and forehead), that in the opinion of the Investigator would interfere with study evaluations.
• •2. Have 3 or more facial inflammatory lesions of rosacea.
• •3. Have an erythema score of 2 (mild), 1 (almost clear), or 0 (clear) on the CEA and/or the PSA at Screening and at Randomization (before drug application on Day 1).
• •4. Patients with excessive facial hair (beards, sideburns, mustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
• •5. Patients with moderate to severe telangiectasial masses in the 5 areas of the entire face: forehead, chin, nose and each cheek, that would interfere with study evaluations.
• •6. History of hypersensitivity or allergy to Mirvaso® including the active ingredient brimonidine tartarate or other component within the formulation.
• •7. Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization.
• •8. Exposed to excessive ultraviolet (UV) radiation within 1 week before screening or randomization visit and/or patient was unwilling to refrain from excessive exposure to UV radiation during the course of the study.
• •9. History of blood dyscrasia.
• •10. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression, or any other condition causing uncontrolled blood flow or blood pressure.
• •11. Females who are pregnant, lactating or likely to become pregnant during the study.
• •12. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation.
• •13. Patients with severe, unstable or uncontrolled cardiovascular disease.
• •14. Patients who meet study restrictions at Screening and Randomization and/or unwillingness to comply with all restricted treatments
• •15. Receipt of any drug as part of a research study within 30 days before dosing.
• •16. Employees of the research center or Investigator.
• •17. Previous participation in this study.
• •18. Patients who are unable and/or unwilling to follow the study requirements, and procedures.