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Clinical Trials/ISRCTN35898459
ISRCTN35898459
Completed
Phase 4

Randomised controlled trial of treatments for pyoderma gangrensoum

ottingham University Hospitals NHS Trust (UK)0 sites140 target enrollmentMay 26, 2009

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Pyoderma gangrenosum (PG)
Sponsor
ottingham University Hospitals NHS Trust (UK)
Enrollment
140
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 26, 2009
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ottingham University Hospitals NHS Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • 1\. PG as diagnosed by the recruiting dermatologist. An ulcerative lesion may have mixed aetiology, but provided the investigator has confidence that a clinical diagnosis of PG is appropriate then they are eligible. Other contributing factors and atypical features will be captured in the case report form.
  • 2\. Must have a measurable ulceration (e.g., not pustular pyoderma gangrenosum)
  • 3\. Age over 18 years, either sex
  • 4\. Able to provide written, informed consent

Exclusion Criteria

  • Patients cannot participate in either arms of the trial if they have any of the following:
  • 1\. Granulomatous PG \- this condition is very rare and may respond differently to treatment
  • 2\. Concomitant ciclosporin, prednisolone or intravenous immunoglobulin (IVIG) therapy in the previous month
  • 3\. Already participating in another clinical trial
  • Exclusions for the randomised controlled trial only are as follows:
  • 4\. Pregnant, lactating or at risk of pregnancy
  • 5\. Hypersensitivity to prednisolone or ciclosporin
  • 6\. Biopsy not consistent with PG
  • 7\. Clinically significant renal impairment that would result in the investigator not normally treating with either study drug
  • 8\. Any pre\-treatment investigations, the results of which would prompt the investigator not to use either study drug

Outcomes

Primary Outcomes

Not specified

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