Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers
Status:
Not yet recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
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.