Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Dr Anwar Tappuni
ORCID ID
http://orcid.org/0000-0002-5370-2423
Contact details
Institute of Dentistry
Barts and The London School of Medicine and Dentistry
Queen Mary University of London
Turner Street
London
E1 2AD
United Kingdom
+44 (0)20 7882 8655
a.r.tappuni@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
06/Q0704/156
Study information
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
Acronym
Study hypothesis
Dual therapy with Colchicine tablets and Betamethasone mouthwash is more effective for RAS that monotherapy with either agents.
Ethics approval
King's College Research Ethics Committee, 20/03/2007, ref: 06/Q0704/156
Study design
Randomised prospective parallel group single-center clinical trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase IV
Drug names
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 trial start date
06/07/2010
Overall trial end date
07/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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.
Recruitment start date
01/12/2010
Recruitment end date
03/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Guys and St Thomas NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Scientific conferences' presentations and scientific journals articles.
IPD sharing statement:
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)
Intention to publish date
12/06/2018
Participant level data
Available on request
Basic results (scientific)
Publication list