Clinical trial: Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers (NCT03888846)

Eligibility criteria:
Inclusion Criteria:

          -  Meets the International Study Group criteria for Behcet's Disease

          -  Presents with at least one active lesions accessible to measurement, the largest of
             which is to be designated as the index ulcer

          -  Index oral ulcer to be assessed should be in the easily accessible areas of the oral
             mucosa, and the oral ulcer first began within 48 hrs prior to enrollment

          -  Adult (>18 years) male or a non-pregnant, non-lactating female

          -  Has signed an Ethics Committee (EC) 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

          -  Is being treated with colchicine

        Exclusion Criteria:

          -  Has a severe, acute, or chronic systemic disease other than Behcet's Disease such as
             congestive heart failure, hepatic failure, renal failure, systemic lupus
             erythematosus, Stevens-Johnson syndrome, ulcerative colitis, cancer, leukemia,
             diabetes, AIDS, or any other condition that is severely compromising the immune system

          -  Has received pentoxifylline in any form over the previous 60 days prior to enrollment

          -  Has experienced recent cerebral and/or retinal hemorrhage or in patients who have
             previously exhibited intolerance to pentoxifylline or methylxanthines such as
             caffeine, theophylline, and theobromine

          -  Has concomitant administration of strong CYP1A2 inhibitors (including e.g.
             ciprofloxacin or fluvoxamine) and other drugs that may increase the exposure to
             pentoxifylline

          -  Is receiving immune suppressing or modulating therapy (e.g., apremilast) or topical
             corticosteroids within 2 weeks prior to enrollment

          -  Is not being treated with colchicine

          -  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 Behcet'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 Behcet's Disease known to cause
             oral ulcerations, such as erosive lichen planus, benign mucous membrane pemphigoid,
             Systemic Lupus Erythematous, Crohn's disease, Reiter's syndrome, or AIDS. Has an
             eating disorder and/or psychiatric illness requiring treatment. 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 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.


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