A randomised clinical trial of the efficacy of topical and systemic treatment on recurrent oral ulcers
| ISRCTN | ISRCTN32677164 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32677164 |
| Secondary identifying numbers | 06/Q0704/156 |
- Submission date
- 02/03/2018
- Registration date
- 15/04/2018
- Last edited
- 04/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Recurrent Aphthous Stomatitis (RAS, also called recurrent oral ulcers), is a common condition that affects up to 10% of the population. Affected patients will have crops of ulcers in their mouth appearing and disappearing spontaneously every so often. The ulcers can be severe sometimes and can cause pain. There are medications that can control these ulcers including prescribed steroid mouthwashes.
This study aims to investigate the effect of steroid mouthwash and Colchicine tablets, used individually and combined to treat ulcers. It also aims to determine the treatment period needed for optimum improvement in RAS.
Who can participate?
Adults aged 18 – 65 years with recurrent aphthous stomatitis (RAS)
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group use Betamethasone sodium phosphate mouthwash for three minutes then discarded, administered four times a day when ulcers are present and twice a day in between ulcer attacks.
Those in group 2 take a Colchicine 500 mcg tablet once daily after breakfast.
Those in the third group take a Colchicine 500 mcg tablet once daily and Betamethasone sodium phosphate mouth rinse for three minutes, four times a day during ulcer attacks only.
All participants are reviewed and assessed at the hospital every three months (five visits in total) and have the following measures taken: history, oral examination, Ulcer Severity Score, medication details, analysis of daily diary, side effects, blood and saliva samples, weight and blood pressure.
What are the possible benefits and risks of participating?
Participants benefit from having therapy for their ulcers and regular assessment of their mouth (at three months intervals for one year). There are no direct risks associated with participation in the study.
Where is the study run from?
Guy’s Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2010 – April 2013
Who is funding the study?
Guys and St Thomas’ NHS Trust
Who is the main contact?
Dr Anwar Tappuni (Public)
a.r.tappuni@qmul.ac.uk
Contact information
Public
Institute of Dentistry
Barts and The London School of Medicine and Dentistry
Queen Mary University of London
Turner Street
London
E1 2AD
United Kingdom
 ORCID ID |
0000-0002-5370-2423 |
|---|---|
| Phone | +44 (0)20 7882 8655 |
| a.r.tappuni@qmul.ac.uk |
Study information
| Study design | Randomised prospective parallel group single-center clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparison of the efficacy of topical betamethasone, systemic colchicine and a combination of both therapies on the severity of recurrent aphthous stomatitis: a randomised clinical trial |
| Study objectives | Dual therapy with Colchicine tablets and Betamethasone mouthwash is more effective for RAS that monotherapy with either agents. |
| Ethics approval(s) | King's College Research Ethics Committee, 20/03/2007, ref: 06/Q0704/156 |
| Health condition(s) or problem(s) studied | Aphthous stomatitis |
| Intervention | Participants are randomly allocated to one of three groups by the clinical trial pharmacist according to a table specifically designed for the trial by a statistician at King's College London. Group 1: Participants are prescribed Betamethasone sodium phosphate mouthwash made up by dissolving 500 mcg tablet in 10ml of water and used as a mouth rinse for 3 minutes then discarded, administered four times a day when ulcers are present and twice a day in between ulcer attacks. Group 2: Participants are prescribed Colchicine 500 mcg tablets to be taken once daily after breakfast. Group 3: Participants are prescribed Colchicine 500 mcg tablets once daily and Betamethasone sodium phosphate 500 mcg tablet dissolved in 10 ml of water and used as a mouth rinse for 3 minutes then discarded, four times a day during ulcer attacks only. All participants are reviewed and assessed at the hospital every three months (five visits) and have the following measures taken: history, oral examination, Ulcer Severity Score, medication details, analysis of daily diary, side effects, blood and saliva samples, weight and blood pressure. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Betamethasone and Colchicine |
| Primary outcome measure | Ulcer severity is measured by a clinician using the Ulcer Severity Score (USS) at baseline, 3, 6, 9 and 12 months, |
| Secondary outcome measures | The level of nine specific cytokines (IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-17, TNF-a and TNF-g) are measured in serum and saliva samples using Fluorokine Multi-Analyte Profiling systems Human Base Kit A in relation to the USS at baseline, 3, 6, 9 and 12 months. |
| Overall study start date | 06/07/2010 |
| Completion date | 07/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Diagnosed with RAS (defined as recurrent oral ulcers of unknown aetiology characterised by the spontaneous emergence of more than two bouts of oral ulcers per year, not associated with ulcers elsewhere in the body or with an underlying systemic abnormality). 2. Aged between 18-65 years. 3. Willing and able to give informed consent to participate in the study. 4. Not involved in other studies that would compromise their safety or undermine the scientific basis of the study. |
| Key exclusion criteria | 1. Unable to give informed consent. 2. Unwilling or unable to comply with the study protocol. 3. Pregnant or breast feeding. 4. Atopic or have severe or relevant history of allergy, hypersensitivity or side effects to any of the study medications. 5. Diagnosed with systemic diseases thought to overlap with RAS i.e. Behcet’s disease, HIV, haematological deficiencies, gastrointestinal or dermatological disorders. 6. Patients with a current or past history of cardiac, renal,or hepatic disease. 7. Patients who were on any type of local or systemic Steroids or on Colchicine currently or in the previous three months. 8. Patients who are debilitated in any way. |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 03/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE1 9RT
United Kingdom
Sponsor information
Hospital/treatment centre
St Thomas Street
London
SE1 9RT
England
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 26/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Scientific conferences' presentations and scientific journals articles. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Stephen Challacombe (Stephen.challacombe@kcl.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/10/2023 | 04/10/2023 | Yes | No |
Editorial Notes
LH 04/10/2023: Added pub from PubMed alert.
26/04/2021: The intention to publish date has been changed from 12/06/2018 to 26/10/2021.
