Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease
NCT ID: NCT06084624
Last Updated: 2023-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2023-12-31
2025-04-30
Brief Summary
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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
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rebamipide mouthwash
Rebamipide mouthwash will be administered four times daily for one week or till healing
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
Betamethasone mouthwash
Betamethasone mouthwash of will be administered four times daily for one week or till healing
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Patients who refuse to sign the informed consent.
18 Years
70 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mostafa Belal Omar Marzouk
Principal investigator
References
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Akagi S, Fujiwara T, Nishida M, Okuda A, Nagao Y, Okuda T, Tokuda H, Takayanagi K. The effectiveness of rebamipide mouthwash therapy for radiotherapy and chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a systematic review and meta-analysis. J Pharm Health Care Sci. 2019 Jul 25;5:16. doi: 10.1186/s40780-019-0146-2. eCollection 2019.
Alibaz-Oner F, Direskeneli H. Advances in the Treatment of Behcet's Disease. Curr Rheumatol Rep. 2021 May 20;23(6):47. doi: 10.1007/s11926-021-01011-z.
Ghate JV, Jorizzo JL. Behcet's disease and complex aphthosis. J Am Acad Dermatol. 1999 Jan;40(1):1-18; quiz 19-20. doi: 10.1016/s0190-9622(99)70523-2.
Hatemi G, Melikoglu M, Tunc R, Korkmaz C, Turgut Ozturk B, Mat C, Merkel PA, Calamia KT, Liu Z, Pineda L, Stevens RM, Yazici H, Yazici Y. Apremilast for Behcet's syndrome--a phase 2, placebo-controlled study. N Engl J Med. 2015 Apr 16;372(16):1510-8. doi: 10.1056/NEJMoa1408684.
Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, Yazici H. Outcome measures used in clinical trials for Behcet syndrome: a systematic review. J Rheumatol. 2014 Mar;41(3):599-612. doi: 10.3899/jrheum.131249. Epub 2014 Feb 1.
International Team for the Revision of the International Criteria for Behcet's Disease (ITR-ICBD). The International Criteria for Behcet's Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):338-47. doi: 10.1111/jdv.12107. Epub 2013 Feb 26.
Kudur MH, Hulmani M. Rebamipide: A Novel Agent in the Treatment of Recurrent Aphthous Ulcer and Behcet's Syndrome. Indian J Dermatol. 2013 Sep;58(5):352-4. doi: 10.4103/0019-5154.117298.
Leccese P, Ozguler Y, Christensen R, Esatoglu SN, Bang D, Bodaghi B, Celik AF, Fortune F, Gaudric J, Gul A, Kotter I, Mahr A, Moots RJ, Richter J, Saadoun D, Salvarani C, Scuderi F, Sfikakis PP, Siva A, Stanford M, Tugal-Tutkun I, West R, Yurdakul S, Olivieri I, Yazici H, Hatemi G. Management of skin, mucosa and joint involvement of Behcet's syndrome: A systematic review for update of the EULAR recommendations for the management of Behcet's syndrome. Semin Arthritis Rheum. 2019 Feb;48(4):752-762. doi: 10.1016/j.semarthrit.2018.05.008. Epub 2018 May 19.
Matsuda T, Ohno S, Hirohata S, Miyanaga Y, Ujihara H, Inaba G, Nakamura S, Tanaka S, Kogure M, Mizushima Y. Efficacy of rebamipide as adjunctive therapy in the treatment of recurrent oral aphthous ulcers in patients with Behcet's disease: a randomised, double-blind, placebo-controlled study. Drugs R D. 2003;4(1):19-28. doi: 10.2165/00126839-200304010-00002.
Nagai N, Seiriki R, Deguchi S, Otake H, Hiramatsu N, Sasaki H, Yamamoto N. Hydrogel Formulations Incorporating Drug Nanocrystals Enhance the Therapeutic Effect of Rebamipide in a Hamster Model for Oral Mucositis. Pharmaceutics. 2020 Jun 9;12(6):532. doi: 10.3390/pharmaceutics12060532.
Novak T, Hamedi M, Bergmeier LA, Fortune F, Hagi-Pavli E. Saliva and Serum Cytokine Profiles During Oral Ulceration in Behcet's Disease. Front Immunol. 2021 Dec 22;12:724900. doi: 10.3389/fimmu.2021.724900. eCollection 2021.
Quijano D, Rodriguez M. [Topical corticosteroids in recurrent aphthous stomatitis. Systematic review]. Acta Otorrinolaringol Esp. 2008 Jun-Jul;59(6):298-307. Spanish.
Senusi A, Kang A, Buchanan JAG, Adesanya A, Aloraini G, Stanford M, Fortune F. New mouthwash: an efficacious intervention for oral ulceration associated with Behcet's disease. Br J Oral Maxillofac Surg. 2020 Oct;58(8):1034-1039. doi: 10.1016/j.bjoms.2020.07.027. Epub 2020 Jul 25.
Tappuni AR, Kovacevic T, Shirlaw PJ, Challacombe SJ. Clinical assessment of disease severity in recurrent aphthous stomatitis. J Oral Pathol Med. 2013 Sep;42(8):635-41. doi: 10.1111/jop.12059. Epub 2013 Mar 19.
Taylor J, Glenny AM, Walsh T, Brocklehurst P, Riley P, Gorodkin R, Pemberton MN. Interventions for the management of oral ulcers in Behcet's disease. Cochrane Database Syst Rev. 2014 Sep 25;2014(9):CD011018. doi: 10.1002/14651858.CD011018.pub2.
Zeidan MJ, Saadoun D, Garrido M, Klatzmann D, Six A, Cacoub P. Behcet's disease physiopathology: a contemporary review. Auto Immun Highlights. 2016 Dec;7(1):4. doi: 10.1007/s13317-016-0074-1. Epub 2016 Feb 12.
Other Identifiers
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3623
Identifier Type: -
Identifier Source: org_study_id
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