Clinical trial: Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea (NCT02289352)

Eligibility criteria:
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 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.

          4. 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).

          5. 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).

          6. 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.

          7. 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.

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

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

        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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21.

Patient description (patient's own words): I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21.

Does the patient match the trial criteria? Contradiction