Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers
Behcet Syndrome, Behcet Disease
About this trial
This is an interventional treatment trial for Behcet Syndrome
Eligibility Criteria
Inclusion Criteria:
- Meets the International Study Group criteria for Behcet's Disease (BD)
- Presents with at least one active genital lesion accessible to measurement
- Adult (>18 years) male or a non-pregnant, non-lactating female
- 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
- Subject's treating physician confirm that the subject has previously had a genital ulcer due to Behcet's Disease
Exclusion Criteria:
- Has a severe, acute, or chronic systemic disease other than BD 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 for which they are immune-compromised
- Has received PTX in any form over the previous 5 days prior to enrollment
- 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 experienced recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine
- Is receiving apremilast or anti-TNF agents such as; Rituximab, Infliximab, Adalimumab, Etanercept (azathioprine, cyclosporine, colchicine, mycophenolate mofetil, interferon and topical or systemic steroid use does not disqualify from enrollment- however, topical steroids should not be used during the treatment period)
- Has concomitant administration of strong CYP1A2 inhibitors (including e.g. ciprofloxacin or fluvoxamine) and other drugs that may increase the exposure to PTX
Sites / Locations
- Silk Road Therapies
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Topical pentoxifylline (PTX) gel
Topical placebo gel
As part of a randomized, placebo-controlled trial with a crossover component, patients who receive topical PTX gel in their initial course of treatment will receive topical placebo gel once they are re-enrolled for their second course of treatment upon recurrence of another crop of genital ulcers.
As part of a randomized, placebo-controlled trial with a crossover component, patients who receive topical placebo gel in their initial course of treatment will receive topical PTX gel once they are re-enrolled for their second course of treatment upon recurrence of another crop of genital ulcers.