NCT01532453终止3 期
Open, Multicentre, Randomised, Comparative, Prospective Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Solid Organ Transplanted Patients for Prevention of UV-induced Carcinogenic Skin Alterations
Spirig Pharma Ltd.11 个研究点 分布在 9 个国家目标入组 244 人开始时间: 2010年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 244
- 试验地点
- 11
- 主要终点
- Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas
研究概览
简要总结
The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.
详细描述
This open-label multicenter, randomized, inter-individual comparative, prospective clinical trial was designed to evaluate the efficacy and safety of MD 3511356 sunscreen in preventing AK and SCC in post transplant immune-suppressed patients compared to standard of care.
The present multicenter trial is intended to contribute to the evidence that daily sun protection will have a prophylactic effect in this high risk population of chronically immune compromised patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-Patients of either sex aged ≥ 40 years
- •Life-expectancy of 2 years at minimum
- •Solid organ-transplant recipients who received a kidney (including pancreas), liver, lung, or heart transplant
- •Patients treated for 5 years with an immunosuppressant medication
- •Severe sun damage of the skin
- •Multiple actinic keratoses (2-5 lesions) and/or multiple dysplastic naevi
- •No present squamous cell carcinoma, basal cell carcinoma or malignant melanoma; but history of cutaneous/cutaneous invasive malignancy with restitutio ad integrum is allowed
- •Patients who are able to understand and provide written informed consent to participate in the clinical trial (signed informed consent) according to ICH GCP
排除标准
- •Non-Caucasian
- •Absence of sun damage i.e. no signs of AK
- •Multi-organ transplantation (exception: simultaneous transplantation of kidney and pancreas)
- •Evidence of systemic infection, except viral hepatitis, at the time of recruitment
- •Known or supposed systemic malignant tumour or systemic chemotherapy within the last 5 years prior to randomisation
- •Patients participating in a clinical trial within the last four weeks before trial
- •Patients treated with the antitumour/antiangiogenetic immunosuppressant sirolimus, respectively everolimus, or acitretin or any other systemic treatment for AK at the time of randomisation
- •Patients treated with a topical drug for the AK at the time of randomisation (exception: excision or Cryotherapy for hyperkeratotic lesions are allowed)
- •Change of the immunosuppression-treatment less than 3 months ago or planned
- •Present or planned interferon therapy (in liver transplant patients with hepatitis B/C)
- •Female patients with childbearing potential with a positive pregnancy test, breast feeding, or female patients with childbearing potential without adequate contraception
结局指标
主要结局
Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas
时间窗: 2 Years
次要结局
- Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas(2 Years)
研究者
研究点 (11)
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