ISRCTN35898459已完成4 期
Randomised controlled trial of treatments for pyoderma gangrensoum
ottingham University Hospitals NHS Trust (UK)0 个研究点目标入组 140 人开始时间: 2009年5月26日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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