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.
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 th...
| Publicado en: | Trials Vol. 13; no. 1; pp. 51 - 52 |
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| Autores principales: | , , , , , , |
| Formato: | research randomized controlled trial Journal Article |
| Publicado: |
BioMed Central
2012
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104425544&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104425544 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17456215 38OC jtl: Trials issn: 17456215 maglogo: N pubinfo: dt: 2012 vid: 13 iid: 1 pid: 24147 pub: BioMed Central artinfo: ui: 104425544 NLM22540770 2011713833 10.1186/1745-6215-13-51 NLM22540770 PMC3423010 104425544 ppf: 51 ppct: 1 formats: tig: atl: 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. aug: au: Craig, Fiona F Thomas, Kim S Mitchell, Eleanor J Williams, Hywel C Norrie, John Mason, James M Ormerod, Anthony D affil: University of Nottingham, Centre of Evidence Based Dermatology, Nottingham, NG7 2NR, UK. sug: subj: Cyclosporine Therapeutic Use Dermatologic Agents Therapeutic Use Prednisolone Therapeutic Use Pyoderma Gangrenosum Drug Therapy Study Design Administration, Oral Cost Benefit Analysis Cyclosporine Administration and Dosage Cyclosporine Adverse Effects Cyclosporine Economics Dermatologic Agents Administration and Dosage Dermatologic Agents Adverse Effects Dermatologic Agents Economics Great Britain Health Care Costs Human Ireland Patient Selection Prednisolone Administration and Dosage Prednisolone Adverse Effects Prednisolone Economics Pyoderma Gangrenosum Economics Pyoderma Gangrenosum Pathology Quality of Life Randomized Controlled Trials Recurrence Time Factors Treatment Outcomes Wound Healing Drug Effects ab: 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.Trial Registration: Current controlled trials: ISRCTN35898459. Eudract No.2008-008291-14. pubtype: Academic Journal doctype: research randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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