Clinical trial NCT00315679: A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Aphthous Stomatitis
Keywords: recurrent aphthous stomatitis
recurrent mouth ulcers
pentoxifylline
clinical trial
double blind
placebo controlled
randomized
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2006-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline (oxpentifylline) for the treatment of recurrent mouth ulcers.

Detailed description: There are few effective treatments for recurrent aphthous stomatitis (cancer sores, recurrent mouth ulcers). Most existing treatments are palliative topical treatments. Some systemic drugs e.g. steroids and thalidomide can suppress the recurrence of mouth ulcers but have serious long term side effects. Pentoxifylline (also known as oxpentifylline) has been used systemically for many years to treat peripheral vascular disease and has a good side effect profile. It shares several actions with thalidomide but does not share its serious side effects. Furthermore, some small scale, open label clinical studies have indicated it may be very effective in treating recurrent aphthous stomatitis (RAS). This study enrolled patients with RAS for which no underlying cause could be identified. Patients kept a diary of the pattern of their mouth ulcers for 60 days to confirm the pattern of ulceration and provide baseline data. Those still qualified for the study were then randomized to treatment with pentoxifylline 400mg three times daily or an identical placebo tablet three times daily for a further 60 days during which they continued to keep a daily ulcer diary. At the end of this period, treatment was stopped and they kept the daily ulcer diary for a further 60 days to identify if any benefit from the treatment was continued after ceasing treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of minor recurrent aphthous stomatitis
* 2 or more mouth ulcers per month for more than 6
* No current treatment for oral ulceration or willing to stop treatment
* Age 16 to 65 years

Exclusion Criteria:

* Taking ketorolac, theophylline or anti-hypertensive medication except diuretics (contra-indicated in patients treated with pentoxifylline)
* Systemic diseases that contra-indicate the use of pentoxifylline i.e. pregnancy, hypotension, ischaemic heart disease, acute myocardial infarction, cerebral or occular hemorrhage, renal or hepatic failure, porphyria or allergy to pentoxifylline.
* Patients with an underlying deficiency state or systemic disease that could cause recurrent mouth ulcers e.g. iron, vitamin B12 or foliate deficience, coeliac disease, Crohn's disease, ulcerative colitis, Behcet's disease or Aids.

Primary outcomes:
measure: Reduction in the median pain score
measure: Reduction in the median ulcer size
measure: Reduction in the median ulcer number
measure: Reduction in the total number of episodes of ulceration (RAS)
Secondary outcomes:
measure: Change in global ulcer severity score
measure: Increase in the proportion of ulcer free days
measure: Difference in the proportion of ulcer free days (comparing trial v baseline)
measure: Side effect incidence
measure: Side effect type
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University Dental Hospital of Manchester
Study officials:
affiliation: University of Sheffield School of Clinical Dentistry
name: Martin H Thornhill, MBBS, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thornhill MH, Baccaglini L, Theaker E, Pemberton MN. A randomized, double-blind, placebo-controlled trial of pentoxifylline for the treatment of recurrent aphthous stomatitis. Arch Dermatol. 2007 Apr;143(4):463-70. doi: 10.1001/archderm.143.4.463.