ActivePhase 3Phase 4ACTRN12608000372381

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.


Sponsor

Hospital das Clínicas, Sao Paulo University

Enrollment

40 participants

Start Date

Feb 2, 2004

Study Type

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

Sex: Both males and femalesMin Age: 10 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing treatments taken by mouth for severe recurrent aphthous stomatitis — a condition where painful mouth ulcers keep coming back frequently. The study is looking at whether systemic (whole-body) medications can reduce the frequency and severity of these ulcers. It is open to people aged 10 and older who experience multiple episodes of mouth ulcers each month.

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.

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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

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)

Brazil

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ACTRN12608000372381