This study is a five year randomised controlled trial to test the hypothesis that ciclosporin (4 mg/kg/day) is more effective than prednisolone (0.75 mg/kg/day) for oral therapy of pyoderma gangrenosum.

Details of the disease

Pyoderma gangrenosum is a very painful skin disease that often affects people with an underlying internal disease (such as inflammatory bowel disease or rheumatoid arthritis).  It starts as a reddish purple bump in the skin that develops into a large, deep, spreading ulcer - often very rapidly.  People with pyodema gangrenosum are often misdiagnosed, and spend a long time in hospital waiting for the affected areas to heal.

Proposed Research

The trial has been set up to evaluate the efficacy and safety of the two most commonly used systematic treatments for pyoderma gangrenosum.  The primary objectives are to assess 'speed of response' to treatments and 'time to complete healing'.  The secondary objectives will be to assess the safety and tolerability of the compared treatments and assess the cost-effectiveness of the treatments.

Outcome measures

The primary outcomes measure will be percentage reduction in surface area of the target lesion (assessed at six weeks) and time to complete healing (follow up for up to six months).

Recruitment

Recruitment is taking place over a four year period, starting April 2009, in approximately 50 hospitals across the UK and Ireland.  Each participant will be enrolled on to the study for up to six months.  If you are interested in helping to recruit to this study please contact the Stop Gap Trial Manager - Eleanor Mitchell tel. 0115 8468634 or email stopgap@nottingham.ac.uk

Funding

This study is funded by the National Institute for Health Research under the Programme Grants for Applied Research.