Overview

Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers

Status:
Unknown status
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
Summary
Although Behçet's Disease (BD) has no FDA-approved therapies, numerous clinical reports suggest that oral ulcers of BD may resolve when treated with systemic ingested pentoxifylline (PTX). The investigators here propose to investigate the therapeutic potential of PTX dissolved in muco-adherent formulation and directly applied to the oral lesions. This 60 patient proof of concept trial is designed to meet regulatory requirements for safety concerns while at the same time exploring the potential efficacy and clinical utility of this product. The investigators hypothesize that application of topical PTX will accelerate the healing of these lesions in a clinically meaningful way, and further hypothesize that topical PTX can become a valuable adjunct to any other systemic therapy for BD.
Phase:
Phase 2
Details
Lead Sponsor:
Ipekyolu Ilac Ltd. Sti
Collaborator:
Istanbul University-Cerrahpasa School of Medicine
Treatments:
Colchicine
Pentoxifylline