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Search / Trial NCT04186559

Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers

Launched by SILK ROAD THERAPIES, INC. · Dec 2, 2019

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a special gel called topical pentoxifylline (PTX) to see if it can help heal genital ulcers caused by Behçet's Disease (BD). BD is a chronic condition that can cause painful sores in different parts of the body, including the mouth and genitals. Genital ulcers are a common and distressing symptom for many patients with BD, and there are currently no approved treatments specifically for these ulcers. Researchers believe that using this gel might speed up the healing process and reduce discomfort for patients.

To participate in the trial, individuals must be over 18 years old, have a confirmed diagnosis of Behçet's Disease, and have at least one active genital ulcer that can be measured. Participants will apply the gel as part of the study and will be monitored to see how well it works. It's important to note that certain health conditions and medications may prevent someone from joining the trial. This study is not yet recruiting, but it aims to provide valuable information on a potential new treatment option for those suffering from genital ulcers due to Behçet's Disease.

Gender

ALL

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

About Silk Road Therapies, Inc.

Silk Road Therapies, Inc. is a clinical-stage biotechnology company dedicated to advancing innovative therapeutic solutions for underserved medical conditions. With a focus on developing novel treatments that leverage advanced biopharmaceutical technologies, the company aims to improve patient outcomes and enhance the quality of life for individuals affected by chronic and complex diseases. Silk Road Therapies is committed to rigorous clinical research and collaboration with healthcare professionals to ensure the efficacy and safety of its products, driving progress in the field of medicine through scientific excellence and patient-centered approaches.

Locations

Washington, District Of Columbia, United States

Patients applied

0 patients applied

Trial Officials

Andew J Sulich, MD

Principal Investigator

Shores Rheumatology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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