EUCTR2014-003691-23-NL进行中（未招募）1 期
Topical Ingenol mebutate versus 5% 5-fluorouracil versus 5% Imiquimod versus photodynamic therapy in the treatment of actinic keratosis: a multi-center randomized efficacy and cost-effectiveness study
Maastricht Universitair Medisch Centrum0 个研究点目标入组 624 人开始时间: 2014年9月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 624
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
入选标准
- •-Patients older than 18 years
- •- Female in child bearing potential should be using contraceptive measures,
- •during and till 3 months post-treatment
- •-Fitzpatrick skintype I-IV
- •-Clinically confirmed diagnosis of AK
- •-One joint area of minimal 25 cm2 and maximal 100 cm2 of AK
- •-AK Olsen grade I-III
- •-Location: head/neck area
- •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 312
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 312
排除标准
- •-Received any kind of treatment for AK in the past 3 months
- •-(N)MSC in target area
- •-Immuno-comprised status
- •-Use of immunosuppressant drugs in the past 3 months and / or at time of
- •treatment (inhalation corticosteroids / nasal corticosteroids are permitted)
- •-Porphyria
- •-Not able to give informed consent
- •-Allergy to study drugs or nut/soy products
- •-Pregnant and breastfeeding women
- •-Genetic skin cancer disorders
- •- No understanding of dutch language
研究者
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