EUCTR2008-008251-42-NL进行中（未招募）不适用
Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN - Effects of HPV-vaccination and imiquimod in VIN patients
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
- 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
- •-Histological proven usual type VIN, without invasion
- •-Previous treatment with imiquimod for 12-16 weeks with a partial response to
- •imiquimod treatment defined as a reduction in lesion size of 26%-99%
- •-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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 or anogenital warts within 1 month of start trial
- •-Hypersensitivity to any components of the vaccine or cream formulation
- •-History of psoriasis or other inflammatory dermatosis of the vulva
- •-Immunodeficiency (e.g. HIV, systemic corticosteroid use)
- •-Insufficient understanding of the Dutch language
- •-Partial responders who are disease-free at study-entry due to other treatment of VIN
研究者
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