Study of treatments for pyoderma gangrenosum

Phase 4

Completed

• Conditions: Pyoderma gangrenosum (PG); Skin and Connective Tissue Diseases; Pyoderma gangrenosum

• Registration Number: ISRCTN35898459
• Lead Sponsor: ottingham University Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-26
• Last Update Posted: 27 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

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
9. A diagnosis of malignancy or pre-malignant disease where treatments might interfere with ongoing therapy or might cause harm (e.g., history of lymphoma, cervical epithelial neoplasia [CIN], systemic cytotoxic therapy)
10. The patient has a concurrent medical condition that means the investigator would not normally treat the patient with either of the study drugs (for example: a degree of hypertension that would not lead to using either of the study drugs, advanced heart failure, poorly-controlled diabetes, history of peptic ulcer, malignancy in previous years)
11. Administration of a live vaccine (bacillus calmette-guerin [BCG], measles, mumps, rubella, yellow fever, oral polio, oral typhoid) within the last 2 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Velocity of healing at 6 weeks. This will be captured for a single target lesion per patient and measured using digital photography and vascular endothelial volume (VEV) computerised planimetry. If multiple lesions are present, the target lesion should be the lesion that is most able to be photographed on a single plane (i.e., not around the curvature of a limb) for study will be the largest of those present. Digital images will be taken at baseline, 6 weeks and when the ulcer has healed (maximum of 6 months). In addition, maximum longitudinal length and maximum perpendicular width will be measured in order to provide some measure of improvement in case of difficulties with the digital images. This will be converted to approximate area by the formula: length x width x 0.785, which approximates to an ellipse for the purpose of randomisation and analysis.