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.
Investigators
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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