Oral Aphthous UlcersPhase 2NCT06084624
Evaluation of Topical Rebamipide Versus Topical Betamethasone for Treatment of Oral Aphthous Ulcers
A Phase 2 study testing Rebamipide mouthwash and Betamethasone mouthwash in people with Oral Aphthous Ulcers, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to to compare the effect of topical rebamipide to topical betamethasone on pain intensity in patients having recurrent oral aphthous ulcers. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Aphthous Ulcers
- What is being tested?
- Rebamipide mouthwash and Betamethasone mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age from 18-70 years old. Patients with active oral ulcers. History of recurrent ulcers in the oral cavity Patients free from any visible oral lesions other than the oral aphthous ulcers.
- Patient who will agree to participate in the study and take the supplied interventions.
- E8glusion 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 under immunosuppressive drugs.
- Patients using topical or systemic treatment agents for the oral ulcers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, Cairo University
Cairo
Mostafa Belal, MSc, 01223384483, mostafa.belal@dentistry.cu.edu.eg
Sherine Ali, Professor, 01280777749, Shereen.Ali@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Topical Rebamipide Versus Topical Betamethasone for Treatment of Oral Aphthous Ulcers: A Randomized Clinical Trial
The goal of this randomized clinical trial is to to compare the effect of topical rebamipide to topical betamethasone on pain intensity in patients having recurrent oral aphthous ulcers. The main question it aims to answer is :
What is the effect of topical Rebamipide mouthwash compared to topical betamethasone mouthwash on pain reduction in patients with oral aphthous ulcers?
Participants will will be divided randomly into the two groups and the following outcomes will be measured:
Pain associated with oral ulcers Number of oral ulcers Diameter of oral ulcers Healing time of oral ulcers
Read the 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 pain intensity in patients having recurrent oral aphthous ulcers.
The participants will be recruited from the pool of the Clinics Medicine, Periodontology and Diagnostic centre, Faculty of Dentistry - Cairo University. 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 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 in the first week (days 3, 5 and 7). 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
- Oral Aphthous Ulcers
- Being tested
- Rebamipide mouthwash, Betamethasone mouthwash
- Keywords
- Oral aphthous ulcers, Oral ulcers, Aphthous ulceration
- Medical subject headings
- Foot-and-Mouth Disease, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebamipide mouthwashDrug
Also called topical rebamipide
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 mouthwashDrug
Also called topical betamethasone
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
| Study group | Role | What they receive |
|---|---|---|
| Rebamipide mouthwash | Experimental | Rebamipide mouthwash will be administered four times daily for one week or till healing Receives: Drug: Rebamipide mouthwash |
| Betamethasone mouthwash | Active comparator | Betamethasone mouthwash of will be administered four times daily for one week or till healing Receives: Drug: Betamethasone mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity associated with oral aphthous ulcers
pain from oral ulcers will be assessed through visual analogue scale
Measured: During the first week (days 0, 3,5 and 7)
Secondary outcomes (3)
Number of oral ulcers
Number of oral ulcers will be determined through clinical examination
Measured: During the first week (days 0, 3,5 and 7)
healing time of oral ulcers
healing time of oral ulcers will be determined through clinical examination
Measured: During the first week (days 0, 3,5, and 7)
Diameter of oral ulcers
Diameter of oral ulcers will be determined through clinical examination
Measured: During the first week (days 0, 3,5 and 7),
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Jul 2026
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Oral Aphthous UlcersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Belal Omar Marzouk, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084624
- Sponsor's protocol ID
- 3623
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma Y, Yang M, Sun J, Qu X, Qu Z, Qu W. The effectiveness of lower-level laser therapy on the treatment of minor recurrent aphthous ulcers: a systematic review and meta-analysis. Lasers Med Sci. 2025 Nov 25;40(1):493. doi: 10.1007/s10103-025-04700-8.
PubMed 41286369Parra-Moreno FJ, Egido-Moreno S, Schemel-Suarez M, Gonzalez-Navarro B, Estrugo-Devesa A, Lopez-Lopez J. Treatment of recurrent aphtous stomatitis: A systematic review. Med Oral Patol Oral Cir Bucal. 2023 Jan 1;28(1):e87-e98. doi: 10.4317/medoral.25604.
PubMed 36173717Rogulj AA, Z Alajbeg I, Brailo V, Skrinjar I, Zuzul I, Vucicevic-Boras V, Alajbeg I. Topical NAVS naphthalan for the treatment of oral lichen planus and recurrent aphthous stomatitis: A double blind, randomized, parallel group study. PLoS One. 2021 Apr 8;16(4):e0249862. doi: 10.1371/journal.pone.0249862. eCollection 2021.
PubMed 33831097Manfredini M, Guida S, Giovani M, Lippolis N, Spinas E, Farnetani F, Dattola A, Di Matteo E, Pellacani G, Giannetti L. Recurrent Aphthous Stomatitis: Treatment and Management. Dermatol Pract Concept. 2021 Sep 1;11(4):e2021099. doi: 10.5826/dpc.1104a99. eCollection 2021 Sep.
PubMed 34631263Alsahaf S, Alkurdi KA, Challacombe SJ, Tappuni AR. Topical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis: a randomised clinical trial. BMC Oral Health. 2023 Oct 3;23(1):709. doi: 10.1186/s12903-023-03335-x.
PubMed 37789351Akagi 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.
PubMed 31367460Kudur 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.
PubMed 24082178Matsuda 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.
PubMed 12568631Nagai 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.
PubMed 32527029Quijano D, Rodriguez M. [Topical corticosteroids in recurrent aphthous stomatitis. Systematic review]. Acta Otorrinolaringol Esp. 2008 Jun-Jul;59(6):298-307. Spanish.
PubMed 18588791