Evaluation of the efficacy of colchicine with and without betamethasone mouthwash in the management of recurrent aphthous stomatitis - ART1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003327-36-GB

Enrollment

192

Registered

2007-01-05

Start date

2007-01-08

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Recurrent aphthous stomatitis (RAS)

Interventions

Trade Name: Colchicine Tablets BP 0.5mg Product Name: Colchichine Tablet BP 0.5mg Pharmaceutical Form: Tablet INN or Proposed INN: Colchicine Tablets B

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with RAS will be recruited from the oral medicine clinic. 1.Patients aged 18-65 years of age 2.Patients are willing and able to give informed consent to the study. 3.Patients will be asked if they are involved in any other research. Care will be taken to ensure that participation in multiple studies will not compromise patient safety or undermine the scientific basis of the study. The overall burden to the participants will be considered. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.Patients under 18 years of age or over 65 years of age 2.Patients who do not adequately understand verbal explanations or written information given in English, or who have special communication needs and unable to give informed consent. 3.Patients who are pregnant or breast feeding. 4.Patients are unwilling or unable to comply with the study protocol 5.Patients with severe or relevant allergy history 6.Patients on systemic steroids 7.Patients who have been taking colchicine or betamethasone mouthwash in the previous three months. 8.Patients with a history of hypersensitivity to colchicine. 9.Patients with blood dyscrasias 10.Patients with a current or past history of any cardiac, renal, hepatic or gastrointestinal disease. 11.Patients who are debilitated in any way.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of topical steroid and Colchicine, individually and combined, in the treatment of RAS. ;Secondary Objective: To assess the effect of therapy on specific immunological markers to determine the mode of action of the drug;Primary end point(s): The primary outcome measure is the Ulcer Severity Score as recorded on the final visit from the clinical history and examination and patient's diary.	—

Measure

Time frame

Main Objective: To assess the efficacy of topical steroid and Colchicine, individually and combined, in the treatment of RAS. ;Secondary Objective: To assess the effect of therapy on specific immunological markers to determine the mode of action of the drug;Primary end point(s): The primary outcome measure is the Ulcer Severity Score as recorded on the final visit from the clinical history and examination and patient's diary.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026