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临床试验/ISRCTN34420460
ISRCTN34420460已完成2 期

A Randomised phase II multi-centre Trial of topical treatment in women with Vulval Intraepithelial Neoplasia (TR3-VIN)

Cardiff University (UK)0 个研究点目标入组 180 人开始时间: 2007年9月25日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
180

研究概览

简要总结

2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25304851 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29336101 long-term follow-up results (added 05/08/2019)

研究设计

研究类型
Interventional

入排标准

性别
Female

入选标准

  • 1. Women with biopsy proven Vulval Intraepithelial Neoplasia 3 (VIN3) (including visible peri-anal disease not extending into the anal canal)
  • 2. At least one lesion of sufficient size to allow biopsies (greater than or equal to 1 cm2)
  • 3. Informed consent

排除标准

  • 1. Any patients with impaired renal function
  • 2. Any patient with current anogenital carcinoma or any patient who, in the investigators opinion, is at a high risk of developing invasive disease (patients in whom invasive or microinvasive disease is suspected should have adequate biopsies to exclude this prior to entry)
  • 3. Pregnancy, breast feeding or trying to conceive
  • 4. Active treatment for VIN within the previous four weeks
  • 5. Patients who are under 18 years old
  • 6. Known allergy to either of the topical treatments
  • 7. Unable to comply with protocol treatment
  • 8. Prior failure of imiquimod or cidofovir following treatment 3 times a week for a minimum of 12 weeks

研究者

发起方
Cardiff University (UK)

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