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

October 13, 2023 updated by: Mostafa Belal Omar Marzouk, Cairo University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients diagnosed with Behcet's disease as defined by the revised International Criteria for Behcet's Disease (ICBD2014).
  2. Patients with active oral ulcers.
  3. Patients free from any visible oral lesions other than the oral ulcers of BD.
  4. Patient who will agree to participate in the study and take the supplied interventions.

Exclusion Criteria:

  1. 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.
  2. Patients who refuse to sign the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rebamipide mouthwash
Rebamipide mouthwash will be administered four times daily for one week or till healing
Drug: Rebamipide mouthwash
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
Other Names:
  • topical rebamipide
Active Comparator: Betamethasone mouthwash
Betamethasone mouthwash of will be administered four times daily for one week or till healing
Drug: Betamethasone mouthwash
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
Other Names:
  • topical betamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oral ulcer severity
Time Frame: During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.
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
Time Frame: During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.
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
Time Frame: 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 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
Time Frame: 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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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