Evaluation of the efficacy of colchicine with and without betamethasone mouthwash in the management of recurrent aphthous stomatitis - ART1
- Conditions
- Recurrent aphthous stomatitis (RAS)
- Registration Number
- EUCTR2006-003327-36-GB
- Lead Sponsor
- Guy's & St Thomas' NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 136
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To assess the efficacy of topical steroid and Colchicine, individually and combined, in the treatment of RAS.<br><br><br> ;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.
- Secondary Outcome Measures
Name Time Method