title: UK Dermatology Clinical Trials Network's STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial.
abstract: BACKGROUND
  Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network's STOP GAP Trial has been designed to address this lack of trial evidence.
  
  
  METHODS
  The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day) to prednisolone (0.75 mg/kg/day). A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) time to healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reported pain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG); measurable ulceration (that is, not pustular PG); and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by lesion size, and presence or absence of underlying systemic disease (for example, rheumatoid arthritis).Patients who require topical therapy are asked to enter a parallel observational study (case series). If topical therapy fails and systemic therapy is required, participants are then considered for inclusion in the randomised trial.
  
  
  BACKGROUND
  Current controlled trials: ISRCTN35898459. Eudract No.2008-008291-14.
authors.affiliation: University of Nottingham, Centre of Evidence Based Dermatology, Nottingham, NG7 2NR, UK.
authors.forename: Fiona F
authors.initials: FF
authors.lastname: Craig
authors.forename: Kim S
authors.initials: KS
authors.lastname: Thomas
authors.forename: Eleanor J
authors.initials: EJ
authors.lastname: Mitchell
authors.forename: Hywel C
authors.initials: HC
authors.lastname: Williams
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.forename: James M
authors.initials: JM
authors.lastname: Mason
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Ormerod
mesh_terms: D000284:Administration, Oral; D003362:Cost-Benefit Analysis; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D016527:Drug Costs; D006801:Humans; D007494:Ireland; D018579:Patient Selection; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D017511:Pyoderma Gangrenosum / Q000188:drug therapy* / Q000191:economics / Q000473:pathology; D011788:Quality of Life; D012008:Recurrence; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014945:Wound Healing / Q000187:drug effects
chemical_list: D003879:Dermatologic Agents; D016572:Cyclosporine; D011239:Prednisolone