Surgical excision versus photodynamic therapy and topical 5-fluorouracil in treatment of Bowen’s disease: a multicenter randomized controlled trial - BOWTIE

azM0 个研究点目标入组 168 人开始时间: 2019年5月14日最近更新: 2019年6月30日

试验速览

暂无简介。

•-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
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 118

•-Bowen's Disease located at ears, periocular, nail , nail unit or periungual tissue, nose (limited light exposure for PDT) and mucous membranes (different entities)
•-High clinical suspicion of invasive SCC
•-(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.

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