Clinical trial: Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea (NCT01355458)

Eligibility criteria:
Key Inclusion Criteria:

          1. Male or female who is at least 18 years of age or older.

          2. A clinical diagnosis of facial rosacea.

          3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening
             and at Baseline/Day 1 (prior to the study drug application).

          4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and
             at Baseline/Day 1 (prior to the study drug application).

        Key Exclusion Criteria:

          1. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated
             rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses
             that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial
             keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
             telangiectasia.

          2. Presence of three (3) or more facial inflammatory lesions of rosacea.

          3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates,
             sedatives, systemic anesthetics, or alpha agonists.

          4. Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac
             glycosides, beta blockers or other antihypertensive agents.

          5. 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.
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