Clinical trial: A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel in Patients With Chronic Persistent Vascular Facial Erythema. (NCT02856919)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female research participants aged 18 or higher.

          2. Patients with chronic persistent facial erythema (at least 1 month before baseline
             [Day 1 hour 0]) of rosacea (with no restrictions to subtypes of rosacea), or
             originated from other dermatological condition, including, but not limited to
             seborrhoeic dermatitis, ulerythema ophryogenes, keratosis pillaris, microneedling,
             fractional radiofrequency, post-peeling treatments (medium depth and deep) or
             post-laser (ablative laser). Diagnosis is based on the investigator clinical
             judgement.

          3. Clinician Erythema Assessment scores 2 (mild), 3 (moderate), or 4 (severe) at Day 1
             prior to study treatment administration.

          4. Patient Self-Evaluation scores 2 (mild), 3 (moderate), or 4 (severe) at Day 1 prior to
             study treatment administration.

          5. Female patients with childbearing potential and negative pregnancy test at baseline.
             These patients should use a highly efficient contraceptive method during the study:
             combined oral contraceptives (estrogen and progesterone) or implanted contraceptives,
             or injectable contraceptives (with a stable dose for at least 1 month before study
             enrolment), bilateral tube ligation, hormonal intrauterine device (inserted at least 1
             month before study entry), strict abstinence (at least 1 month prior to study entry
             and agreement in continuing throughout the study), or vasectomized partner (at least 3
             months prior to study entry).

          6. Female patients without childbearing potential (e.g., before menstruating,
             post-menopausal [absence of menstrual bleeding for 1 year prior to study entry],
             hysterectomy, or bilateral oophorectomy, less than one year after menopause).

          7. Patients willing and able to fulfill the protocol requirements and duration.

          8. Patients who understand and sign the Informed Consent Form at study inclusion, before
             any study procedure is carried out.

        Exclusion Criteria:

        - Any research participant that meets one or more of the following criteria is not eligible
        for the trial:

          1. Female patients who are pregnant, breastfeeding or planning for pregnancy.

          2. Current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives,
             systemic anesthetics or alpha agonists.

          3. Patients who started or changed their doses of tricyclic antidepressants, cardiac
             glycosides, beta-blockers or other anti-hypertensive agents, in the 3 months prior to
             study entry.

          4. Current diagnosis of Raynaud syndrome, thromboangiitis obliterans, orthostatic
             hypotension, severe cardiovascular disease, coronary or cerebral insufficiency,
             hepatic or renal failure, sclerodermia, Sjögren syndrome, or depression.

          5. Any chronic or severe uncontrolled disease or medical chronic which may interfere with
             the interpretation of the study results, or may present a significant healthcare risk
             to the patient, if he/she participates in the study in accordance with the
             investigator judgment. (e.g. endocrine tumors, chromocytomas, systemic diseases that
             cause vascular erythema).

          6. Known or suspected allergies or hypersensitivities to any of the components of the
             study treatments, including the active substance of brimonidine tartrate (see summary
             of product characteristics).

          7. Patients who received, applied or ingested the following treatments in accordance with
             the time period specified before Day 1:

               -  Topic facial treatments or procedures:

             Any dermatological/surgical facial procedure - 4 weeks. Immunomodulators (e.g.
             Methotrexate, Cyclosporin) - 4 weeks. Mirvaso® - 4 weeks.

               -  Systemic treatments:

             Isotretinoin - 6 months. Immunomodulators - 90 days. Phototherapy - 4 weeks.

          8. Exposure to excessive ultraviolet radiation within a week before Day 1 visit.

          9. Presence of beard or excessive facial hair at Day 1, which interferes with the study
             treatment or study assessments and refusal to remove it during the study period.

         10. Patients who do not wish to abstain from the use of forbidden medication or excessive
             exposure to ultraviolet radiation during the study period.

         11. Vulnerable research participants (as deprived of freedom), in accordance with Section
             1.61 of the International Conference on Harmonization of Technical Requirements for
             Registration of Pharmaceuticals for Human Use - ICH for Good Clinical Practices.

         12. Current participation in any other clinical study with a drug or device OR
             participation within 30 days prior to Day 1 OR in an exclusion period of a previous
             clinical study (when possible).
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