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Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers

NCT03888846 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-08-03

No results posted yet for this study

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.

Conditions

  • Behçet Disease Affecting Oral Mucosa

Interventions

DRUG

Pentoxifylline

Topical gel version of pentoxifylline to be administered intraorally.

DRUG

Colchicine

Colchicine therapy is provided to patients with oral ulcers as part of supportive care routinely offered by Behcet's Clinic-Istanbul.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    collaborator OTHER

  • Ipekyolu Ilac Ltd. Sti

    lead INDUSTRY

Principal Investigators

  • Gulen Hatemi, MD · Istanbul Universitesi-Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2019-08-31
Completion
2019-09-30
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03888846 on ClinicalTrials.gov