EUCTR2010-019422-13-AT进行中（未招募）不适用
An open monocentric pilot study to investigate the potential of imiquimod 5% cream to detect residual and to prevent recurrence of lentigo maligna after surgical excision
Medical University of Graz0 个研究点开始时间: 2010年7月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible, a patient must comply with all of the following criteria:
- •1.Having undergone surgical excision of LM or LMM.
- •2.Positive histological finding of LM or LMM (positive histology of primary
- •3.Age = 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient is ineligible and must not enter the study if any of the following criteria is met:
- •Safety concerns:
- •1.History of allergic reaction to imiquimod or its excipients.
- •2.Pregnancy, breast-feeding or planned pregnancy during the study and women of child-bearing potential not using adequate contraception. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.
- •Lack of suitability for the study:
- •3.History of malignant melanoma having metastasised or where metastasis could be expected.
- •4.Other malignant tumours in the study treatment area (exception actinic keratosis (AK)).
- •Administrative reasons:
- •5.Lack of ability or willingness to give informed consent.
- •6.Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
- •7.Anticipated non-availability for study visits/procedures.
研究者
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