Condition category
Oral Health
Date applied
02/03/2018
Date assigned
15/04/2018
Last edited
26/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Guys and St Thomas NHS Trust

Sponsor details

St Thomas Street
London
SE1 9RT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes