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 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction