Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT03888846
• Date of registration: 21/03/2019
• Prospective Registration: Yes
• Primary sponsor: Ipekyolu Ilac Ltd. Sti
• Public title: Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers
• Scientific title: Clinical Protocol for Administration of Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers
• Date of first enrolment: March 25, 2019
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03888846
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Turkey

Contacts

• Name: Gulen Hatemi, MD
• Affiliation: Istanbul Universitesi-Cerrahpasa

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Behçet Disease Affecting Oral Mucosa

Intervention(s)

Drug: Colchicine

Drug: Pentoxifylline

Primary Outcome(s)

Mean change in the speed of healing of the index oral ulcer [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).]

Mean change in patient reported outcome pain scores [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.]

Mean change in the total number of oral ulcers [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.]

Secondary Outcome(s)

Behcet's Disease Activity Index [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.]

Behcet's Disease-Quality of Life Assessment Questionnaire [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.]

Secondary ID(s)

P104375V04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Istanbul University - Cerrahpasa (IUC)