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

Inclusion Criteria

• Male or non-pregnant, non-lactating female, 18 years of age or older.
• Signed informed consent form, which meets all criteria of current FDA regulations.
• Females of child bearing potential must not be pregnant or lactating at Screening and Randomization (as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing 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 diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. A sterile sexual partner is not considered an adequate 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 12 consecutive months, without other known or suspected primary cause.
• Have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks prior to Screening. 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 the past 12 months.
• Females who have been amenorrhea for ≥ 12 months, but the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.
• Have a clinical diagnosis of facial rosacea and fewer than 3 inflammatory lesions on the face at Screening and at Randomization (before drug application on Day 1).
• Have moderate to severe facial erythema according to both CEA and PSA (i.e., an erythema score of 3 or more for each of the CEA and PSA) at Screening and at Randomization (before drug application on Day 1).
• Free from any systemic or dermatologic disorder (other than rosacea) that, in the opinion of the Investigator, will interfere with the study evaluations or increase the risk of AEs.
• Willing to minimize external factors that might trigger rosacea flare-ups (e.g., hot environments, prolonged sun exposure, strong winds and emotional stress) within 24 hours of the Screening and Randomization visit.
• Any skin type or race, providing the skin pigmentation will allow discernment of erythema.
• Willingness and capability to cooperate to the extent and degree required by the protocol.

Exclusion Criteria

• 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.
• Have 3 or more facial inflammatory lesions of rosacea.
• 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).
• Patients with excessive facial hair (beards, sideburns, mustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
• 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.
• History of hypersensitivity or allergy to Mirvaso® including the active ingredient brimonidine tartarate or other component within the formulation.
• Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization.
• Exposed to excessive ultraviolet (UV) radiation within 1 week before screening or randomization visit