NL-OMON49810招募中4 期
Surgical excision versus photodynamic therapy and topical 5-fluorouracil in treatment of Bowen*s disease: a multicenter randomized controlled trial - BOWTIE
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 250 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
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
- 年龄范围
- 18 至 99（—）
入选标准
- •-Adults >= 18 years
- •-Histologically proven primary Bowen*s disease
- •-Lesions >= 4mm and <= 40mm in diameter
- •-Fitzpatrick skin type I-IV
- •-Female in child bearing potential should be using contraceptive measures,
- •during and till 3 months post-treatment
排除标准
- •-Bowen's Disease located at ears, periocular, nail , nail unit or periungual
- •tissue, nose (limited light exposure for PDT), genital and mucous membranes
- •(different entities)
- •-High clinical suspicion of invasive SCC
- •-Interfering treatment of other (N)MSC in target area
- •-Breastfeeding
- •-Pregnancy
- •-Allergy to study drugs
- •-Not able to self-apply cream on lesions located on the back or other difficult
- •to reach locations
- •-Genetic skin cancer disorders
- •-Not understanding Dutch language
- •-Porphyria
- •-Not able to give informed consent
- •-Immuno-compromised status
- •-Use of systemic retinoid in the past 3 months
- •-Use of immunosuppressant drugs in the past 3 months and / or at time of
- •treatment (such as oral glucocorticoids, cytostatic, antibodies, drug acting on
- •immunophilins, in-terferon, opioids, TNF binding proteins, MMF, biologic
- •agents). inhalation corticoster-oids / nasal corticosteroids are permitted.
研究者
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