Clinical trial

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

Name

3623

Description

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

Trial arms

Trial start

2023-12-01

Estimated PCD

2025-01-01

Trial end

2025-04-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

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

Arms:

Rebamipide mouthwash

Other names:

topical rebamipide

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

Arms:

Betamethasone mouthwash

Other names:

topical betamethasone

Size

Primary endpoint

oral ulcer severity

During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-10-16

1 organization

2 products

1 indication

Organization

Product

Indication

Product