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

Primary Purpose

Oral Ulceration Due to Behçet's Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Rebamipide mouthwash
Betamethasone mouthwash
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Ulceration Due to Behçet's Disease focused on measuring Behcet Disease, Oral ulcers, oral ulceration

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Rebamipide mouthwash

    Betamethasone mouthwash

    Arm Description

    Rebamipide mouthwash will be administered four times daily for one week or till healing

    Betamethasone mouthwash of will be administered four times daily for one week or till healing

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Pain associated with oral ulcers
    pain from oral ulcers will be assessed through visual analogue scale
    Number of oral ulcers
    Number of oral ulcers will be determined through clinical examination
    healing time of oral ulcers
    healing time of oral ulcers will be determined through clinical examination

    Full Information

    First Posted
    October 10, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06084624
    Brief Title
    Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease
    Official Title
    Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    April 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Ulceration Due to Behçet's Disease
    Keywords
    Behcet Disease, Oral ulcers, oral ulceration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantCare ProviderInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Rebamipide mouthwash
    Arm Type
    Experimental
    Arm Description
    Rebamipide mouthwash will be administered four times daily for one week or till healing
    Arm Title
    Betamethasone mouthwash
    Arm Type
    Active Comparator
    Arm Description
    Betamethasone mouthwash of will be administered four times daily for one week or till healing
    Intervention Type
    Drug
    Intervention Name(s)
    Rebamipide mouthwash
    Other Intervention Name(s)
    topical rebamipide
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Betamethasone mouthwash
    Other Intervention Name(s)
    topical betamethasone
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    oral ulcer severity
    Description
    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
    Time Frame
    During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.
    Secondary Outcome Measure Information:
    Title
    Pain associated with oral ulcers
    Description
    pain from oral ulcers will be assessed through visual analogue scale
    Time Frame
    During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.
    Title
    Number of oral ulcers
    Description
    Number of oral ulcers will be determined through clinical examination
    Time Frame
    During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.
    Title
    healing time of oral ulcers
    Description
    healing time of oral ulcers will be determined through clinical examination
    Time Frame
    During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease

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