Topical Pentoxifylline Gel for Behcet's Disease Genital Ulcers

Recruiting in Palo Alto (17 mi)

Overseen byAndew J Sulich, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Silk Road Therapies, Inc.

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Prior Safety Data

Trial Summary

What is the purpose of this trial?

Behçet's Disease (BD) is a complex, chronic, relapsing, multi-system inflammatory disorder that is characterized by oral ulcers, genital ulcers in addition to ocular and skin symptoms. Genital ulcers are the second most common symptom of BD and occur in 57-93% of BD patients. The genital ulcers of BD clearly cause considerable morbidity for those affected. This will be one of the first trials of a topical product designed for accelerated healing of BD genital ulcers. There is no cure or FDA-approved therapies for BD genital ulcers and the treatment of recurrent genital ulcers that are associated with BD is palliative. Recent study evaluating the effect of topical PTX on BD oral ulcers suggests that topical pentoxifylline (PTX) might have an immediate impact on BD oral ulcer healing leading to accelerated ulcer clearance, which results in lower daily ulcer numbers for the patients along with reduced pain scores. Investigators hypothesize that application of topical PTX will accelerate the healing of BD genital ulcers in a similar clinically meaningful way, and further hypothesize that topical PTX can become a valuable adjunct to any other systemic therapy for BD.

Eligibility Criteria

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.

Inclusion Criteria

My doctor confirmed I've had genital ulcers from Behcet's Disease.

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

I have been diagnosed with Behcet's Disease according to international criteria.

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Exclusion Criteria

I have not had recent brain or eye bleeding and am not allergic to this drug or similar stimulants.

I do not have severe diseases like heart failure, liver failure, kidney failure, lupus, Stevens-Johnson syndrome, ulcerative colitis, cancer, leukemia, diabetes, AIDS, or any condition that weakens my immune system.

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

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Treatment Details

Interventions

Topical Pentoxifylline Gel (Other)

Trial OverviewThe 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.

Participant Groups

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.