EUCTR2011-003134-13-NL进行中（未招募）不适用
5-Aminolevulinic Acid PhotoDynamic Therapy for the treatment of premalignant disorders of the vulva. - ALA-PDT for premalignant vulvar disorders
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
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
- Female
入选标准
- •- Histologically proven usual type VIN, without invasion or histologically proven LS.
- •- The patient is willing to use a medically acceptable method of contraception throughout the study.
- •- Age 18 and above.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •- (Micro-)invasive carcinoma.
- •- Pregnancy and/or breastfeeding.
- •- Past history of vulvar cancer.
- •- Differentiated (non HPV-related) VIN.
- •- Other treatment of VIN, anogenital warts or LS within 1 month of start treatment.
- •- Hypersensitivity to any components of the cream formulations.
- •- History of psoriasis or other inflammatory dermatosis of the vulva.
- •- Insufficient understanding of the Dutch language.
研究者
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