Clinical trial: MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea. (NCT02616250)

Eligibility criteria:
Main Inclusion Criteria:

          1. Male or female subjects age 18 years or older;

          2. Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and
             pustules) of rosacea on the face;

          3. Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored
             3 or 4 according to Clinician's Erythema Assessment [CEA]);

          4. Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to
             the Investigator's Global Assessment [IGA]);

          5. Female subjects of childbearing potential with a negative urine pregnancy test (UPT);

          6. Female subjects of childbearing potential must practice a highly effective method of
             contraception during the study;

          7. Females subjects of non-childbearing potential;

        Main Exclusion Criteria:

          1. Subjects with particular forms of rosacea or other concomitant facial dermatoses that
             may be confounded with rosacea;

          2. Subjects with more than 2 nodules of rosacea on the face;

          3. Subjects with any uncontrolled chronic or serious disease or medical condition that
             may either interfere with the interpretation of the clinical trial results, or with
             optimal participation in the study or would present a significant risk to the subject;

          4. Subjects with known or suspected allergies or sensitivities to any component of the
             investigational and non-investigational products, including the active ingredients
             brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;
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? Entailment