Clinical trial: Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea (NCT00617903)

Eligibility criteria:
Inclusion Criteria:

          -  male and female patient at least 18 years of age

          -  signed informed consent

          -  Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or
             pustules, persistent erythema, and telangiectasia

          -  Ability and willingness to accept and comply with treatment and required medical
             examinations

        Exclusion Criteria:

          -  Known non-responders to azelaic acid

          -  Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea

          -  Presence of dermatoses that could interfere with the rosacea diagnosis

          -  Treatment with isotretinoin in the six months prior to randomization

          -  Treatment of the face with topical retinoids during the two weeks prior to
             randomization

          -  Treatment with oral antibiotics during the four weeks prior to randomization

          -  Treatment with topical antibiotics

          -  Treatment with systemic corticosteroids during 4 weeks prior to randomization

          -  Treatment of the face with topical corticosteroids during 2 weeks prior to
             randomization

          -  Treatment of the face with topical imidazole antimycotics during 2 weeks prior to
             randomization

          -  Treatment of the face with topical azelaic acid formulations during 2 weeks prior to
             randomization

          -  Use of a sauna during 2 weeks prior to randomization and during the study

          -  Facial laser surgery for telangiectasia during 6 weeks prior to randomization

          -  Planned concurrent use of any treatment other than study medication that affects
             rosacea

          -  History of hypersensitivity to propylene glycol or any other ingredient of the study
             drugs

          -  Participation in another clinical trial during the last 4 weeks
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