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

Trials

Volumn 13, Issue , 2012, Pages

  Craig, Fiona F ^a   Thomas, Kim S ^b   Mitchell, Eleanor J ^c   Williams, Hywel C ^b   Norrie, John ^d   Mason, James M ^f   Ormerod, Anthony D ^e  

^a ABERDEEN ROYAL INFIRMARY   (United Kingdom)

^b UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^c QUEEN S MEDICAL CENTRE   (United Kingdom)

^d UNIVERSITY OF ABERDEEN   (United Kingdom)

^e UNIVERSITY OF ABERDEEN   (United Kingdom)

^f DURHAM UNIVERSITY   (United Kingdom)

Author keywords

Ciclosporin (cyclosporin); Prednisolone; Pyoderma gangrenosum; RCT

Indexed keywords

CYCLOSPORIN; CYCLOSPORIN A; PREDNISOLONE; DERMATOLOGICAL AGENT;

ADULT; ARTICLE; CLINICAL PROTOCOL; COST EFFECTIVENESS ANALYSIS; COST UTILITY ANALYSIS; DERMATOLOGY LIFE QUALITY INDEX; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; HUMAN; IRELAND; MULTICENTER STUDY (TOPIC); PAIN; PYODERMA GANGRENOSUM; PYODERMA GANGRENOSUM INFLAMMATION ASSESSMENT SCALE SCORE; QUALITY ADJUSTED LIFE YEAR; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENCE RISK; SCORING SYSTEM; SELF REPORT; SYSTEMIC THERAPY; TREATMENT OUTCOME; TREATMENT RESPONSE; ULCER HEALING; UNITED KINGDOM; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; DRUG COST; DRUG EFFECT; ECONOMICS; METHODOLOGY; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PATHOLOGY; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; TIME; WOUND HEALING;

ADMINISTRATION, ORAL; COST-BENEFIT ANALYSIS; CYCLOSPORINE; DERMATOLOGIC AGENTS; DRUG COSTS; GREAT BRITAIN; HUMANS; IRELAND; PATIENT SELECTION; PREDNISOLONE; PYODERMA GANGRENOSUM; QUALITY OF LIFE; RECURRENCE; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME; WOUND HEALING;

EID: 84862164735     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-51     Document Type: Article

References (19)

1. Craig F, Ormerod A. Pyoderma gangrenosum: pathogenesis, diagnosis, classification and treatment. J Clin Dermatol 2011, 1:1-9.
2. Powell FC, Daniel Su WP, Perry HO. Pyoderma gangrenosum: classification and management. J Am Acad Dermatol 1996, 34:395-409. 10.1016/S0190-9622(96)90428-4, 8609250.
3. Bennett ML, Jackson JM, Jorizzo JL, Fleischer AB, White WL, Callen J. Pyoderma gangrenosum: a comparison of typical and atypical forms with an emphasis on time to remission. Case review of 86 patients from 2 institutions. Medicine (Baltimore) 2000, 79:37-46.
4. Powell FC, Schroeter AL, Su WP, Perry HO. Pyoderma gangrenosum: a review of 86 patients. Q J Med 1985, 55:173-186.
5. von den Driesch P. Pyoderma gangrenosum: a report of 44 cases with follow-up. Br J Dermatol 1997, 167:1000-1005.
6. Reichrath J, Bens G, Bonowitz A. Treatment recommendations for pyoderma gangrenosum: an evidence-based review of the literature based on more than 350 patients. J Am Acad Dermatol 2005, 53:273-283. 10.1016/j.jaad.2004.10.006, 16021123.
7. Prajapati V, Man J, Brassard A. Pyoderma gangrenosum: common pitfalls in management and a stepwise, evidence-based, therapeutic approach. J Cutan Med Surg 2009, 13:S2-S11.
8. Brooklyn TN, Dunnill MG, Shetty A, Bowden JJ, Williams JD, Griffiths CE, Forbes A, Greenwood R, Probert CS. Infliximab for the treatment of pyoderma gangrenosum: a randomised, double blind, placebo controlled trial. Gut 2006, 55:505-509. 10.1136/gut.2005.074815, 1856164, 16188920.
9. STOP GAP Trial STOP GAP Trial website. [http://www.stopgaptrial.co.uk], STOP GAP Trial.
10. Lyon CC, Stapleton M, Smith AJ, Mendelsohn S, Beck MH, Griffiths CE. Topical tacrolimus in the management of peristomal pyoderma gangrenosum. J Dermatolog Treat 2001, 12:13-17. 10.1080/095466301750163518, 12171681.
11. Nybaek H, Olsen AG, Karlsmark T, Jemec GB. Topical therapy for peristomal pyoderma gangrenosum. J Cutan Med Surg: Inc Med Surg Dermatol 2004, 8:220-223.
12. Wunderlich RP, Peters EJ, Armstrong DG, Lavery LA. Reliability of digital videomatery and acetate tracing in measuring the surface area of cutaneous wounds. Diabetes Res Clin Pract 2000, 49:87-92. 10.1016/S0168-8227(00)00145-5, 10963818.
13. Kantor J, Margolis DJ. A multi-centre study of percentage change in venous leg ulcer area as a prognostic index of healing at 24 weeks. Br J Dermatol 2000, 142:960-964. 10.1046/j.1365-2133.2000.03478.x, 10809855.
14. Foss CE, Clark AR, Inabinet R, Camacho F, Jorizzo JL. An open-label pilot study of alefacept for the treatment of pyoderma gangrenosum. J Euro Acad Dermatol 2008, 22:943-949.
15. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI): a simple practical measure for routine clinical use. Clin Exp Dermatol 1994, 19:210-216. 10.1111/j.1365-2230.1994.tb01167.x, 8033378.
16. Brookes R. EuroQol - the current state of play. Health Policy 1996, 37:53-72. 10.1016/0168-8510(96)00822-6, 10158943.
17. UK Dermatology Clinical Trials Network UK Dermatology Clinical Trials Network's website. [http://www.ukdctn.org], UK Dermatology Clinical Trials Network.
18. NIHR Clinical Research Network NIHR Clinical Research Network website. [http://www.crncc.nihr.ac.uk], NIHR Clinical Research Network.
19. Nottingham Clinical Trials Unit Nottingham Clinical Trials Unit website. [http://ctu.nottingham.ac.uk], Nottingham Clinical Trials Unit.