Clinical trial: Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea (NCT01025635)

Eligibility criteria:
Inclusion Criteria:

          -  Signed written informed consent

          -  Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum
             of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent
             erythema with or without telangiectasia

          -  Free of any clinically significant disease which could interfere with the study

          -  Willingness to follow all study procedures

          -  Male or female patient at least 18 years of age

        Exclusion Criteria:

          -  Subjects known to be non-responders to azelaic acid

          -  Presence of dermatoses that might interfere with the rosacea diagnosis or the
             evaluation of treatment results

          -  Ocular rosacea, phymatous rosacea

          -  Any condition or therapy that in the opinion of the investigator may pose a risk to
             the patient of interfere with any evaluation in the study

          -  Facial laser surgery in the 6 weeks prior to the study

          -  Topical or systemic use of prescription or non-prescription medications to treat
             rosacea

          -  Use of any agent other than the investigational drugs to treat rosacea during the
             study

          -  Expected use or change in dose in the 90 days prior to the study of beta-blockers,
             vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions

          -  Known hypersensitivity to any ingredients of the investigational product formulation

          -  Alcohol or drug abuse

          -  Incapability of giving fully informed consent

          -  Subject is dependent person, i.e., a relative/family member of the investigator and/or
             is a member of the investigator's staff

          -  Participation in another clinical research study within the last 4 weeks before
             randomization in this study
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? 1