Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease

Study Overview
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Brief Summary
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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

Detailed Description
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This is a Randomized clinical trial (RCT) parallel groups, two arm, equivalence framework with 1:1 allocation ratio which is based on the hypothesis that Topical rebamipide has comparable effect to topical betamethasone on oral ulcer severity in patients with Behcet's disease The participants in this study will be recruited from the Rheumtology Clinic, Kasr el ainy hospital by HL as well as Oral Medicine Clinic and the dental Diagnostic center, Faculty of Dentistry, by MB. The eligible participants will be enrolled in the study in a consecutive order till the sample size is achieved. Simple randomization will be generated using computerized random number generator (random.org) with allocation ratio (1:1). Allocation concealment will be done using sequentially numbered opaque sealed opaque containers of the same shape, size and colour until interventions are assigned. The entire procedure will be explained to the patients and a written consent will be obtained by the operator. Participants and care givers will be blinded as both topical rebamipide and topical betamethasone mouthwashes will be of same consistency and will be provided in sealed opaque containers of the same shape, size and colour. The enrolled patients will be divided randomly into two groups. One group will receive topical rebamipide mouthwash four times daily for one week or till healing and the other group will receive topical Corticosteroid (topical betamethasone) four times daily for one week or till healing. The patients will be recalled during the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months. The patients will be asked to prohibit use of any topical medication during the trial. Outcome measures will be recorded in each visit. Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 24 (SPSS Inc., Chicago, IL)

Official Title
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Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease: A Randomized Clinical Trial

Conditions
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Oral Ulceration Due to Behçet's Disease

Intervention / Treatment
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* Drug: Rebamipide mouthwash
* Drug: Betamethasone mouthwash


Participation Criteria
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Eligibility Criteria
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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. Patients who refuse to sign the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a parallel 2 arm randomized controlled clinical trial where one group will be assigned to the rebamipide mouthwash, while the other group will be assigned to the betamethasone group randomly.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebamipide mouthwash<br>Rebamipide mouthwash will be administered four times daily for one week or till healing | Drug: Rebamipide mouthwash<br>* Rebamipide (REB), 2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinone-4-yl]-propionic acid, is commonly used in cases of gastric ulcers, gastritis, and dry eye syndrome<br>* Other names: topical rebamipide;|
| Active Comparator: Betamethasone mouthwash<br>Betamethasone mouthwash of will be administered four times daily for one week or till healing | Drug: Betamethasone mouthwash<br>* Betamethasone is a potent glucocorticoid steroid. It is very soluble in water, and therefore it can be used as a mouthwash and has been used for symptomatic relief and treatment of recurrent aphthous ulcers<br>* Other names: topical betamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral ulcer severity | oral ulcer severity score (OUSS). OUSS indicates the disease activity in recurrent oral ulcers., as the change in the numerical score reflects the change in ulcer severity in response to treatment | During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain associated with oral ulcers | pain from oral ulcers will be assessed through visual analogue scale | During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months. | 
| Number of oral ulcers | Number of oral ulcers will be determined through clinical examination | During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months. | 
| healing time of oral ulcers | healing time of oral ulcers will be determined through clinical examination | During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behcet Disease, Oral ulcers, oral ulceration