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Topical Pentoxifylline Gel for Behcet's Disease Genital Ulcers

Phase 2
Waitlist Available
Led By Andew J Sulich, MD
Research Sponsored by Silk Road Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets the International Study Group criteria for Behcet's Disease (BD)
Presents with at least one active genital lesion accessible to measurement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the participants will be assessed at thirteen time points (or until the complete healing of genital ulcers) for each treatment period. each treatment period is estimated to take 30 days. there will be a final follow-up 30 days after the treatment.
Awards & highlights

Study Summary

This trial is testing a new gel to see if it can help heal genital ulcers caused by Behçet's Disease. The disease causes ulcers in the mouth, genitals, and on the skin, and can be painful. There is no cure or FDA-approved therapies for the disease, so this gel could be helpful for those affected.

Who is the study for?
This trial is for adults over 18 with Behcet's Disease who have at least one genital ulcer. Participants must meet specific criteria for BD, have had a previous BD-related genital ulcer, and be able to follow the study rules. Pregnant or breastfeeding women and those with severe diseases like heart failure or immune-compromised conditions cannot join.Check my eligibility
What is being tested?
The trial tests a topical gel containing Pentoxifylline (PTX) against a placebo gel for healing genital ulcers in Behcet's Disease patients. The goal is to see if PTX can speed up healing and reduce pain compared to no active treatment.See study design
What are the potential side effects?
Potential side effects of the PTX gel may include local skin reactions such as redness, itching, or irritation at the application site. Since it's applied topically, systemic side effects are less likely but could include symptoms similar to caffeine intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Behcet's Disease according to international criteria.
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I have at least one genital sore that can be measured.
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I am an adult over 18 and if female, not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the participants will be assessed at thirteen time points (or until the complete healing of genital ulcers) for each treatment period. each treatment period is estimated to take 30 days.there will be a final follow-up 30 days after the treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the participants will be assessed at thirteen time points (or until the complete healing of genital ulcers) for each treatment period. each treatment period is estimated to take 30 days.there will be a final follow-up 30 days after the treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in patient reported outcome pain scores in numeric rating scale
Mean change in total number of genital ulcers
Mean time to healing of genital ulcers

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical pentoxifylline (PTX) gelExperimental Treatment2 Interventions
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.
Group II: Topical placebo gelPlacebo Group2 Interventions
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.

Find a Location

Who is running the clinical trial?

Silk Road Therapies, Inc.Lead Sponsor
Andew J Sulich, MDPrincipal InvestigatorShores Rheumatology

Media Library

Topical Pentoxifylline Gel (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04186559 — Phase 2
Behcet's Disease Research Study Groups: Topical pentoxifylline (PTX) gel, Topical placebo gel
Behcet's Disease Clinical Trial 2023: Topical Pentoxifylline Gel Highlights & Side Effects. Trial Name: NCT04186559 — Phase 2
Topical Pentoxifylline Gel (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04186559 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailments does Topical pentoxifylline (PTX) gel typically ameliorate?

"Topical pentoxifylline (PTX) gel can be effectively utilized to treat alcoholic liver diseases, venous leg ulcers (VLU), and intermittent claudication."

Answered by AI

Are there still slots available for participation in this research endeavor?

"The clinicaltrials.gov website confirms that the initial posting of this trial was on February 1st 2024 and it has not been updated since August 2nd 2023; thus, no new participants are being accepted at present. Nonetheless, there are presently 19 other medical studies actively recruiting patients into them."

Answered by AI

Are there any recorded precedents of utilizing Topical pentoxifylline (PTX) gel in clinical trials?

"Presently, 10 clinical trials for the Topical pentoxifylline (PTX) gel are in progress. Two of these experiments have proceeded to Phase 3 and 36 sites across the United States are running tests on this treatment. Lexington, Kentucky is hosting most of its research efforts related to PTX gel."

Answered by AI

Has the FDA sanctioned topical pentoxifylline gel for medical use?

"The safety of Topical pentoxifylline (PTX) gel is assessed as a 2, per our team at Power's assessment. This evaluation considers the fact that this trial is Phase 2; meaning there are some indications suggesting safety but no evidence supporting efficacy yet."

Answered by AI

What is the total number of participants taking part in this research?

"Regrettably, the clinical trial we discussed is no longer recruiting. It was initially posted on February 1st 2024 and had its last update on August 2nd 2023. For those who are still searching for trials to join, there are 9 studies admitting participants with Behcet's disease and 10 examining topical pentoxifylline (PTX) gel that have openings for volunteers."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers
2024. "Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04186559.
~33 spots leftby Nov 2024
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