Clinical trial: An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea (NCT03352323)

Eligibility criteria:
Inclusion Criteria:

          1. Male or non-pregnant, non-lactating female, 18 years of age or older.

          2. Signed informed consent form that meets all criteria of current Food and Drug
             Administration regulations.

          3. Females of childbearing potential must not be pregnant or lactating.

          4. Females of childbearing potential must agree to the use of a reliable method of
             contraception throughout the study.

          5. Have clinical diagnosis of rosacea with persistent (non-transient) facial erythema.

          6. Have < 3 inflammatory lesions on the face.

          7. Have an erythema score of 3 (moderate) or 4 (severe) for both the CEA and the PSA that
             is reflective of the overall targeted areas.

          8. Willing to minimize external factors that might trigger rosacea flare-ups (e.g., spicy
             foods, hot drinks, hot environments, prolonged sun exposure, strong winds, emotional
             stress and alcoholic beverages) during the study.

        Exclusion Criteria:

          1. Forms of rosacea that, in the opinion of the Investigator, would interfere with the
             diagnosis or assessment of study endpoints

          2. Patient has a skin condition that, in the opinion of the Investigator, would interfere
             with the diagnosis or assessment of rosacea

          3. Patients with active sunburn or excessive facial hair such as beards, sideburns,
             moustaches, etc.

          4. Patients with moderate to severe telangiectasial masses

          5. History of blood dyscrasia.

          6. Significant history or current evidence of any uncontrolled chronic or serious disease
             or medical condition that would, in the judgment of the Investigator, would put the
             subject at undue risk or compromise the study assessments.

          7. History or current evidence of Raynaud's syndrome, severe, unstable or uncontrolled
             cardiovascular disease, orthostatic hypotension, uncontrolled hypertension or
             hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, renal or
             hepatic or renal impairment, scleroderma, Sjögren's syndrome, depression, or
             narrow-angle glaucoma to an extent that, in the opinion of the Investigator, would
             place the subject at undue risk.

          8. Female patients taking hormonal contraceptives or oral estrogen for less than one
             month or those that plan to change the dosage regimen during the course of the study.

          9. Previous participation in this study.

         10. Employees of the Investigator or research center or their immediate family members.

         11. Inability to understand the requirements of the study and the relative information and
             are unable or not willing to comply with the study protocol.
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