Study of treatments for pyoderma gangrenosum patients

• Research type

  Research Study

• Full title

  Study of treatments for pyoderma gangrenosum patients (STOP GAP)

• IRAS ID

  11086

• Contact name

  Hywel Williams

• Sponsor organisation

  Nottingham University Hospitals NHS Trust

• Eudract number

  2008-008291-14

• ISRCTN Number

  CRN 5692

• Research summary

  Pyoderma gangrenosum (PG) is a very painful skin disease that can affectpeople with other diseases such as inflammatory bowel disease and rheumatoid arthritis. It starts as a reddish purple bump in the skin that can develop into a large ulcer in a matter of days. PG can be very difficult to treat and there is currently no ??gold-standard?? treatment, although steroids and immunosuppressants are often used. However, there have been no randomised controlled trials investigating the best treatment for PG. Both prednisolone (steroid) and ciclosporin (immunosuppressant) are associated with unpleasant and damaging side-effects, and are currently being used for patients without rigorous testing or understanding of how effective they are for PG.This study will look at how effective and safe the two most commonly used systemic treatments are. The study aims to test the assumption that ciclosporin is more effective than prednisolone in the treatment of PG. Ciclosporin gains control of PG more rapidly and thus reduces the time to healing.Participants will be randomly allocated to receive either prednisolone or ciclosporin. There is also an ??observational?? group of participants who will receive treatment with topical therapy. Participants in the trial will attend four trial visits and will be asked to complete a short daily diary until the ulcer has healed or for 6 months (whichever comes first). Photographs of the ulcer will be taken to assess how quickly the ulcer is healing. These will be analysed by an assessor who will not know which medication the patient has been taking. The trial is a pragmatic trial that has been designed to reflect normal care and therefore the dose of treatment can be altered. Participants are being recruited into the trial from Dermatology Departments around the UK.

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/5

• Date of REC Opinion

  15 Feb 2009

• REC opinion

  Further Information Favourable Opinion