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Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers

Primary Purpose

Behçet Disease Affecting Oral Mucosa

Status

Completed

Phase

Phase 2

Locations

Turkey

Study Type

Interventional

Intervention

Pentoxifylline

Colchicine

About this trial

This is an interventional treatment trial for Behçet Disease Affecting Oral Mucosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meets the International Study Group criteria for Behcet's Disease
Presents with at least one active lesions accessible to measurement, the largest of which is to be designated as the index ulcer
Index oral ulcer to be assessed should be in the easily accessible areas of the oral mucosa, and the oral ulcer first began within 48 hrs prior to enrollment
Adult (>18 years) male or a non-pregnant, non-lactating female
Has signed an Ethics Committee (EC) approved subject consent form
Has completed all screening procedures satisfactorily, is deemed to be an acceptable subject and is otherwise eligible for entry into the study
Is willing and able to comply with the protocol
Is being treated with colchicine

Exclusion Criteria:

Has a severe, acute, or chronic systemic disease other than Behcet's Disease such as congestive heart failure, hepatic failure, renal failure, systemic lupus erythematosus, Stevens-Johnson syndrome, ulcerative colitis, cancer, leukemia, diabetes, AIDS, or any other condition that is severely compromising the immune system
Has received pentoxifylline in any form over the previous 60 days prior to enrollment
Has experienced recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine
Has concomitant administration of strong CYP1A2 inhibitors (including e.g. ciprofloxacin or fluvoxamine) and other drugs that may increase the exposure to pentoxifylline
Is receiving immune suppressing or modulating therapy (e.g., apremilast) or topical corticosteroids within 2 weeks prior to enrollment
Is not being treated with colchicine
Is under active treatment for dental conditions, such that multiple dental office visits would be required during the study period, or presents with oral conditions which are not thought to be related to Behcet's Disease and in the judgment of a qualified dentist, will require treatment during the study period
Is suffering from any medical condition other than Behcet's Disease known to cause oral ulcerations, such as erosive lichen planus, benign mucous membrane pemphigoid, Systemic Lupus Erythematous, Crohn's disease, Reiter's syndrome, or AIDS. Has an eating disorder and/or psychiatric illness requiring treatment. 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. Has any abnormality in hematological or biochemical variable, which, in the opinion of the principal investigator, would place the subject at increased risk during study therapy

Sites / Locations

Istanbul Universitesi-Cerrahpaşa Tıp Fakültesi, İç Hastalıkları Anabilim Dalı-Romatoloji

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Colchicine

Topical Pentoxifylline Gel and Colchicine

Arm Description

Colchicine therapy as part of supportive care routinely offered in Behcet's Clinic-Istanbul

Topical Pentoxifylline Gel administration in addition to the colchicine therapy as part of supportive care routinely offered in Behcet's Clinic-Istanbul

Outcomes

Primary Outcome Measures

Mean change in the speed of healing of the index oral ulcer

The size of the index oral ulcer will be measured at study enrollment and during the two week trial at seven time points (Please see Schedule of Activities in the protocol for more detail). The change in the size of the index ulcer will be compared between two study arms.

Mean change in the total number of oral ulcers

The total number of oral ulcer will be measured at study enrollment and during the two week trial at seven time points (Please see Schedule of Activities in the protocol for more detail). The total number of oral ulcers will be compared between two study arms.

Mean change in patient reported outcome pain scores

Pain scores will be compared between two study arms as measuring pain offers an opportunity to correlate simple measurements of oral mucosal disruption with patient's fundamental disease experience.

Secondary Outcome Measures

Behcet's Disease-Quality of Life Assessment Questionnaire

Participant's quality of life will be assessed by a Behcet's Disease specific questionnaire prepared by key opinion leaders in the field of Behcet's Disease research at the University of Leeds. Please see the "Behcet's Disease Quality of Life Measure" in the appendix of the protocol for more details.

Behcet's Disease Activity Index

Behcet's Disease Activity Index is prepared by International Society for Behcet's Disease to guide the doctor in assessing the disease activity.

Full Information

NCT ID

NCT03888846

First Posted

March 21, 2019

Last Updated

August 2, 2023

Sponsor

Ipekyolu Ilac Ltd. Sti

Collaborators

Istanbul University - Cerrahpasa (IUC)

1. Study Identification

Unique Protocol Identification Number

NCT03888846

Brief Title

Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers

Official Title

Clinical Protocol for Administration of Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

March 25, 2019 (Actual)

Primary Completion Date

August 31, 2019 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipekyolu Ilac Ltd. Sti

Collaborators

Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

Behçet's Clinic at Cerrahpaşa Medical Faculty at the University of Istanbul has a long history of supportive care for BD patients and is recognized as the world leader in this regard. According to the EULAR 2018 recommended guidelines of Behcet's Disease, the first line of therapy recommended against recurring oral ulcers is colchicine. However, a significant portion of the participants undergoing colchicine therapy does not have sufficient response and require subsequent immune modulatory therapy. By comparing participants receiving colchicine as part of supportive care to those who also receive topical pentoxifylline (PTX), the investigators seek to prove the concept that topical PTX may have clinical value. Additionally, the investigators seek to demonstrate the safety and practicality of using topical PTX in BD patients. If the PTX gel therapy provides a sufficient response in participants, these participants might not need to undergo immune modulatory therapies. The risks of PTX are well characterized and previously reported adverse events were primarily gastrointestinal. The investigators expect fewer GI symptoms to result from the topical PTX application. The investigators anticipate the benefits of PTX can be optimized by a topical application, but require a trial to test that hypothesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Behçet Disease Affecting Oral Mucosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Colchicine

Arm Type

Other

Arm Description

Colchicine therapy as part of supportive care routinely offered in Behcet's Clinic-Istanbul

Arm Title

Topical Pentoxifylline Gel and Colchicine

Arm Type

Experimental

Arm Description

Topical Pentoxifylline Gel administration in addition to the colchicine therapy as part of supportive care routinely offered in Behcet's Clinic-Istanbul

Intervention Type

Drug

Intervention Name(s)

Pentoxifylline

Other Intervention Name(s)

Trental

Intervention Description

Topical gel version of pentoxifylline to be administered intraorally.

Intervention Type

Drug

Intervention Name(s)

Colchicine

Other Intervention Name(s)

Colchicum-Dispert

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean change in the speed of healing of the index oral ulcer

Description

Time Frame

The participants will be assessed at seven time points starting at enrollment when the index ulcer is assigned until the complete healing(disappearance) of the index oral ulcer. This time frame is estimated to take two weeks (please see SoA in protocol).

Title

Mean change in the total number of oral ulcers

Description

Time Frame

The participants will be assessed at seven time points starting at the enrollment visit until the end of study visit. This time frame is estimated to take two weeks.

Title

Mean change in patient reported outcome pain scores

Description

Pain scores will be compared between two study arms as measuring pain offers an opportunity to correlate simple measurements of oral mucosal disruption with patient's fundamental disease experience.

Time Frame

The participants will be assessed at sixteen time points starting at the enrollment visit until the final follow up visit.This time frame is estimated to take 45 days. Please see Schedule of Activities(SoA) in the protocol.

Secondary Outcome Measure Information:

Title

Behcet's Disease-Quality of Life Assessment Questionnaire

Description

Time Frame

The participants will be assessed at eight time points starting at the enrollment visit until the final follow up visit.This time frame is estimated to take 45 days. Please see Schedule of Activities(SoA) in the protocol.

Title

Behcet's Disease Activity Index

Description

Behcet's Disease Activity Index is prepared by International Society for Behcet's Disease to guide the doctor in assessing the disease activity.

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meets the International Study Group criteria for Behcet's Disease Presents with at least one active lesions accessible to measurement, the largest of which is to be designated as the index ulcer Index oral ulcer to be assessed should be in the easily accessible areas of the oral mucosa, and the oral ulcer first began within 48 hrs prior to enrollment Adult (>18 years) male or a non-pregnant, non-lactating female Has signed an Ethics Committee (EC) approved subject consent form Has completed all screening procedures satisfactorily, is deemed to be an acceptable subject and is otherwise eligible for entry into the study Is willing and able to comply with the protocol Is being treated with colchicine Exclusion Criteria: Has a severe, acute, or chronic systemic disease other than Behcet's Disease such as congestive heart failure, hepatic failure, renal failure, systemic lupus erythematosus, Stevens-Johnson syndrome, ulcerative colitis, cancer, leukemia, diabetes, AIDS, or any other condition that is severely compromising the immune system Has received pentoxifylline in any form over the previous 60 days prior to enrollment Has experienced recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine Has concomitant administration of strong CYP1A2 inhibitors (including e.g. ciprofloxacin or fluvoxamine) and other drugs that may increase the exposure to pentoxifylline Is receiving immune suppressing or modulating therapy (e.g., apremilast) or topical corticosteroids within 2 weeks prior to enrollment Is not being treated with colchicine Is under active treatment for dental conditions, such that multiple dental office visits would be required during the study period, or presents with oral conditions which are not thought to be related to Behcet's Disease and in the judgment of a qualified dentist, will require treatment during the study period Is suffering from any medical condition other than Behcet's Disease known to cause oral ulcerations, such as erosive lichen planus, benign mucous membrane pemphigoid, Systemic Lupus Erythematous, Crohn's disease, Reiter's syndrome, or AIDS. Has an eating disorder and/or psychiatric illness requiring treatment. 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. Has any abnormality in hematological or biochemical variable, which, in the opinion of the principal investigator, would place the subject at increased risk during study therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gulen Hatemi, MD

Organizational Affiliation

Istanbul Universitesi-Cerrahpasa

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istanbul Universitesi-Cerrahpaşa Tıp Fakültesi, İç Hastalıkları Anabilim Dalı-Romatoloji

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All of the individual participant data collected during the trial, after deidentification will be available to other researchers.

IPD Sharing Time Frame

Beginning 3 months following publication. No end date.

IPD Sharing Access Criteria

Proposals should be directed to bderkunt@gmail.com. Anyone who provides a methodologically sound proposal will be approved to perform any type of analysis to achieve the aims in the proposals. To gain access, data requestors will need to sign a data access agreement. Data will be made available indefinitely at (link to be included).

Learn more about this trial

Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers

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