A randomised clinical trial of the efficacy of topical and systemic treatment on recurrent oral ulcers

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32677164

Enrollment

100

Registered

2018-04-15

Start date

2010-12-01

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphthous stomatitis Oral Health Recurrent aphthous stomatitis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Ulcer severity is measured by a clinician using the Ulcer Severity Score (USS) at baseline, 3, 6, 9 and 12 months,	—

Secondary

Measure	Time frame
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.	—

Countries

England, United Kingdom

Contacts

Public ContactAnwar Tappuni

a.r.tappuni@qmul.ac.uk+44 (0)20 7882 8655

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026