Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Be… (NCT06084624) | Clinical Trial Compass
UnknownPhase 1/2
Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease
40 participantsStarted 2023-12
Plain-language summary
The goal of this randomized clinical trial is to to compare the effect of topical rebamipide to topical betamethasone on oral ulcer severity in patients with Behcet's disease.. The main question it aims to answer is :
What is the effect of topical Rebamipide mouthwash compared to topical betamethasone mouthwash in management of oral ulcers in Behcet's disease?
Participants will will be divided randomly into the two groups and the following outcomes will be measured:
The oral ulcers severity Pain associated with oral ulcers Number of oral ulcers Healing time of oral ulcers
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients diagnosed with Behcet's disease as defined by the revised International Criteria for Behcet's Disease (ICBD2014).
. Patients with active oral ulcers.
. Patients free from any visible oral lesions other than the oral ulcers of BD.
. Patient who will agree to participate in the study and take the supplied interventions.
Exclusion criteria
. Patients with history of a severe or chronic medical condition including congestive heart failure, malignancy and active infection including tuberculosis, hepatitis and human immunodeficiency virus.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/2 trial comparing rebamipide to betamethasone for Behçet's oral ulcers, what does that early phase mean for how much is already known about rebamipide's safety and effectiveness specifically for my condition?
2Betamethasone is already used as a standard topical treatment for Behçet's oral ulcers — could you help me understand whether starting with that established option might make more sense for me than joining a trial where one arm is still being studied?
3The trial's recruitment status is listed as unknown, so is this study still actively enrolling patients, and how would we find out if I could even be considered for it?
4How is 'oral ulcer severity' being measured in this trial, and would participating require me to come in for frequent in-person assessments that might be hard to fit around my schedule?
5Given that Behçet's disease can also affect other parts of my body beyond oral ulcers, would focusing on a trial targeting only oral symptoms be the right priority for my overall disease management right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
oral ulcer severity
Timeframe: During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.