Clinical trial: A Safety and Efficacy Study to Evaluate Rosacea (NCT03883945)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy male and/or female subjects between the ages of 18 and 65 year with rosacea,
             10 to 30 papules and pustules (at least 5 lesions within the treatment area on each
             facial side), and < 2 nodules

          -  Presence of moderate to severe persistent erythema

          -  Total body weight >45 kg

        Exclusion Criteria:

          -  Presence of any skin condition on the face that would interfere with the diagnosis or
             assessment of rosacea

          -  Extremely dark skin type that would confound the digital analysis of erythema (eg,
             Fitzpatrick Skin Type 5 or 6)

          -  Excessive facial hair (eg, beards, sideburns, moustaches, etc.), birthmarks, or
             tattoos that would interfere with diagnosis or assessment of rosacea

          -  Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
             cigarettes per day.

          -  Pregnant or nursing females; females of childbearing potential who are unwilling or
             unable to use an acceptable method of non-hormonal contraception as outlined in this
             protocol from at least 14 days prior to start of treatment.

          -  Hypersensitivity or allergy to axitinib or any other component of the study treatment

          -  Use within 6 months prior to baseline and during the study of oral retinoids (eg,
             Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day
             (multivitamins are allowed).

          -  Use within 6 weeks prior to baseline and during the study of vasodilators or
             α-adrenergic receptor-blocking agents.

          -  Use within 1 month prior to baseline and during the study of 1) topical retinoids to
             the face, 2) systemic antibiotics know to have an impact on the severity of facial
             rosacea (eg, containing tetracycline and its derivatives, erythromycin and its
             derivatives, sulfamethoxazole, or trimethoprim), 3) systemic corticosteroids, or 4)
             facial light-based therapies
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.
Subject must be at most 65 Years

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? 1