EUCTR2013-002951-14-GB进行中（未招募）1 期
Human papillomavirus infection: a randomised controlled trial of Imiquimod cream (5%) versus Podophyllotoxin cream (0.15%), in combination with quadrivalent human papillomavirus or control vaccination in the treatment and prevention of recurrence of anogenital warts (HIPvac Trial) - HIPvac Trial
niversity College London0 个研究点目标入组 503 人开始时间: 2019年1月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 503
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
入选标准
- •Males and females
- •First episode or repeat episode of anogenital warts diagnosed clinically
- •External anogenital warts considered, in the opinion of the investigator, to be suitable for selfadministered
- •wart treatment (patients with concurrent internal anogenital warts are still eligible to participate).
- •Able to provide informed consent to participate in the trial.
- •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 1000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous wart treatment in the last 3 months
- •Previous quadrivalent HPV vaccine (previous bivalent HPV vaccine is not an exclusion criterion).
- •Previous intolerance to either of the topical treatments, vaccines or their constituents
- •Known HIVpositivity
- •(HIV testing is not required for the trial).
- •Pregnancy or lactation (current, or planned in the next 6 months)
- •Women of child bearing potential not willing to use effective contraception for the duration and 30 days post
- •completion of trial treatment: see above
- •Unable or unwilling to complete followup
- •Lesion area greater than 4 cm2, requiring treatment under direct supervision of medical staff (in accordance with
- •podophyllotoxin cream Summary of Product Characteristics).
- •Patients who have had topical steroids applied to the target area, or systemic steroids or other immunosuppressive
- •agents, within 1 month prior to randomisation
- •Patients enrolled in any other trial of an Investigational Medicinal Product, without the permission of the Chief
- •Investigator.
- •Any clinical condition which the
研究者
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