A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315679
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : April 19, 2006
Information provided by:
Manchester University NHS Foundation Trust

April 18, 2006
April 19, 2006
April 19, 2006
June 1996
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  • Reduction in the median pain score
  • Reduction in the median ulcer size
  • Reduction in the median ulcer number
  • Reduction in the total number of episodes of ulceration (RAS)
Same as current
No Changes Posted
  • Change in global ulcer severity score
  • Increase in the proportion of ulcer free days
  • Difference in the proportion of ulcer free days (comparing trial v baseline)
  • Side effect incidence
  • Side effect type
Same as current
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A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis
Not Provided
This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline (oxpentifylline) for the treatment of recurrent mouth ulcers.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Recurrent Aphthous Stomatitis
Drug: Pentoxifylline (also known as oxpentifylline)
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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. Erratum in: Arch Dermatol. 2007 Jun;143(6):716.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 1998
Not Provided

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.
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Manchester University NHS Foundation Trust
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Principal Investigator: Martin H Thornhill, MBBS, BDS University of Sheffield School of Clinical Dentistry
Manchester University NHS Foundation Trust
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP