Clinical trial: Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea (NCT01555463)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of papulopustular rosacea

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

          -  Male or female subject aged ≥ 18 years

          -  Willingness of subject to follow all study procedures

          -  Signed written informed consent before any study-related activities are carried out

        Exclusion Criteria:

          -  Subjects who are known to be non-responders to azelaic acid

          -  Presence of dermatoses that might interfere with rosacea diagnosis

          -  Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions,
             papulopustular rosacea that requires systemic treatment

          -  Topical use of any prescription or non-prescription medication to treat rosacea within
             6 weeks prior to randomization and throughout the study

          -  Systemic use of any prescription or non-prescription medication to treat rosacea
             (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids,
             erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to
             randomization and throughout the study

          -  Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to
             randomization

          -  Known hypersensitivity to any ingredients of the investigational product formulation

          -  Participation in another clinical research in parallel or within the last 4 weeks
             before randomization in this study

          -  Any condition or therapy that in the investigator's opinion may pose a risk to the
             subject or that could interfere with any evaluation in the 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