Systemic treatment in severe cases of recurrent aphthous stomatitis
A trial investigating the effects of thalidomide, dapsone, colchicine and/or pentoxifilline in preventing recurrent aphthous stomatitis (RAS) bouts in patients with severe RAS manifestations.
Hospital das Clínicas, Sao Paulo University
40 participants
Feb 2, 2004
Interventional
Conditions
Summary
The main purpose of this study is to evaluate the efficacy of systemic drugs in the treatment of patients with severe recurrent aphthous stomatitis.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
thalidomide - 100mg/day; 6 months, tablets orally pentoxifylline - 400mg, three times/day; 6 months, tablets orally colchicine - 0.5mg/day for 7 days; 1.0mg/day for 7 days; 1.5mg/day as maintenance dose; 6 months, tablets orally dapsone - 25mg/day for 3 days; 50mg/day for 3 days; 75mg/day for 3 days; 100mg/day as maintenance dose; 6 months, tablets orally. Subjects will receive any of the drugs listed above, switching from one drug to another according to their response to treatment and severity of adverse effects. Subjects will be followed fortnightly for a 6-month period during medication use, and monthly for another 6 months of follow-up period. As an open trial designs it will be considered the thalidomide group as a comparator (active control) due to the good results registered in previous trials, nevertheless the study will show some characteristics of a crossover study since if a patient do not get any improvement or exhibit severe adverse effects to the first given drug, that subject will be allocated to another testing drug.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12608000372381