Clinical trial: Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease (NCT00483184)

Eligibility criteria:
Inclusion Criteria:

          -  Is a male or a non-pregnant, non-lactating female.

          -  Has a history and clinical presentation consistent with a diagnosis of Behçet's
             Disease and meets International Study Group criteria (Appendix B).

          -  Has a history of oral ulcers for at least 12 months.

          -  Has a history of monthly episodes of multiple oral ulcers.

          -  Has the presence of at least 2 oral ulcers at study entry, both of which are
             accessible to measurement, with a total diameter of at least 4 mm.

          -  Has signed an IRB approved subject consent form.

          -  Has completed all screening procedures satisfactorily, is deemed to be an acceptable
             subject and is otherwise eligible for entry into the study.

          -  Is willing and able to comply with the protocol.

        Exclusion Criteria:

          -  Has a severe, acute, or chronic systemic disease other than Behçet's Disease such as
             congestive heart failure, hepatic failure, renal failure, Systemic Lupus Erythematosus
             (SLE), Stevens-Johnson syndrome, ulcerative colitis, cancer, leukemia, diabetes, AIDS
             or ARC, or any other condition for which they are immunocompromised.

          -  Is under active treatment for dental conditions, such that multiple dental office
             visits would be required during the study period, or presents with oral conditions
             which are not thought to be related to Behçet's Disease and, in the judgment of a
             qualified dentist, will require treatment during the study period.

          -  Is suffering from any medical condition other than Behçet's Disease known to cause
             oral ulcerations, such as erosive lichen planus, benign mucous membrane pemphigoid,
             SLE, Crohn's disease, Reiter's syndrome, or AIDS.

          -  Has an eating disorder and/or psychiatric illness requiring treatment.

          -  Has hypersensitivity to interferon-alpha.

          -  Is a pregnant or lactating female, or is of childbearing potential and is not using a
             medically acceptable contraceptive method throughout the study.

          -  Has had previous exposure to any parenteral interferon therapy.

          -  Has had exposure to IFNα lozenges within 30 days of screening.

          -  Has had exposure to thalidomide within 30 days of screening.

          -  Has had exposure to methotrexate within 30 days of screening.

          -  Has had exposure to any immune-suppressive medication within 30 days of screening.

          -  Has a history of, or is currently exhibiting, any disease or condition which, in the
             opinion of the Principal Investigator, would place the subject at increased risk
             during study therapy.

          -  Has any abnormality in a hematological or biochemical variable which, in the opinion
             of the Principal Investigator, would place the subject at increased risk during study
             therapy.
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.
Subject must be at most 75 Years

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