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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000372381

Enrollment

Registered

2008-07-31

Start date

2004-02-02

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

10 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with severe clinical course of RAS, i.e., multiple episodes of ulcers monthly

Exclusion criteria

Patients with hematologic disease, Behçet's syndrome, Crohn's disease, Human immunodeficiency virus (HIV) infection or Reiter's syndrome.

Outcome results