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

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, 18 years of age or older.

2. Signed informed consent form, which meets all criteria of current FDA regulations.

3. Females of child bearing potential must not be pregnant or lactating at Screening andRandomization (as confirmed by a negative urine pregnancy test with a sensitivity ofless than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women ofchildbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragmwith spermicide], oral, transdermal, injected or implanted non- or hormonalcontraceptive), throughout the study. A sterile sexual partner is not considered anadequate form of birth control. All females will be considered to be of childbearing potential unless they:

• Are post-menopausal, defined as women who have been amenorrheic for at least 12consecutive months, without other known or suspected primary cause.

• Have been sterilized surgically or who are otherwise proven sterile (i.e., totalhysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks prior toScreening. Tubal ligation will not be considered a surgically sterile method. Female patients of childbearing potential are defined as:

• Women without prior hysterectomy, or who have had any evidence of menses in thepast 12 months.

• Females who have been amenorrhea for ≥ 12 months, but the amenorrhea is possiblydue to other causes, including prior chemotherapy, anti-estrogens, or ovariansuppression.

4. Have a clinical diagnosis of facial rosacea and fewer than 3 inflammatory lesions onthe face at Screening and at Randomization (before drug application on Day 1).

5. Have moderate to severe facial erythema according to both CEA and PSA (i.e., anerythema score of 3 or more for each of the CEA and PSA) at Screening and atRandomization (before drug application on Day 1).

6. Free from any systemic or dermatologic disorder (other than rosacea) that, in theopinion of the Investigator, will interfere with the study evaluations or increase therisk of AEs.

7. Willing to minimize external factors that might trigger rosacea flare-ups (e.g., hotenvironments, prolonged sun exposure, strong winds and emotional stress) within 24hours of the Screening and Randomization visit.

8. Any skin type or race, providing the skin pigmentation will allow discernment oferythema.

9. Willingness and capability to cooperate to the extent and degree required by theprotocol.

Exclusion Criteria:

1. Patients with particular forms of rosacea (rosacea conglobata, rosacea fulminans,isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facialdermatoses similar to rosacea, such as peri-oral dermatitis, demodicidosis, facialkeratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinictelangiectasia, 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 studyevaluations.

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/orthe PSA at Screening and at Randomization (before drug application on Day 1).

4. Patients with excessive facial hair (beards, sideburns, mustaches, etc.) that wouldinterfere with the diagnosis or assessment of rosacea.

5. Patients with moderate to severe telangiectasial masses in the 5 areas of the entireface: forehead, chin, nose and each cheek, that would interfere with studyevaluations.

6. History of hypersensitivity or allergy to Mirvaso® including the active ingredientbrimonidine tartarate or other component within the formulation.

7. Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior torandomization.

8. Exposed to excessive ultraviolet (UV) radiation within 1 week before screening orrandomization visit and/or patient was unwilling to refrain from excessive exposure toUV radiation during the course of the study.

9. History of blood dyscrasia.

10. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatichypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renalor hepatic impairment, scleroderma, Sjögren's syndrome, or depression, or any othercondition 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, systemdisorder, organ disorder or other medical condition that in the Investigator's opinionwould 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/orunwillingness 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, andprocedures.