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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06084624

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Oral Ulceration Due to Behçet's Disease	Drug: Rebamipide mouthwash Drug: Betamethasone mouthwash	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

the allocation of the participants to the groups will be concealed . The bottles of both mouthwashes will be the same. The solution of both mouthwashes will be of the same colour, odor and consistency.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

oral ulcer severity [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

Secondary Outcome Measures

Pain associated with oral ulcers [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
Number of oral ulcers [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
healing time of oral ulcers [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.