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)

niversity College London (UK)0 个研究点目标入组 503 人开始时间: 2014年7月25日最近更新: 2020年10月12日

适应症

试验速览

•1. Age 18 years or over
•2. Males and females
•3. First episode or repeat episode of anogenital warts diagnosed clinically
•4. External anogenital warts considered, in the opinion of the investigator, to be suitable for self-administered topical wart treatment (patients with concurrent internal anogenital warts are still eligible to participate)
•5. Able to provide informed consent to participate in the trial

•1. Previous wart treatment in the last 3 months
•2. Previous quadrivalent HPV vaccine (previous bivalent HPV vaccine is not an exclusion criterion)
•3. Previous intolerance to either of the topical treatments, vaccines or their constituents
•4. Known HIV-positivity (HIV testing is not required for the trial)
•5. Pregnancy or lactation (current, or planned in the next 6 months)
•6. Women of child bearing potential not willing to use effective contraception for the duration and 30 days post completion of trial treatment: see above
•7. Unable or unwilling to complete follow-up procedures
•8. Lesion area greater than 4 cm2, requiring treatment under direct supervision of medical staff (in accordance with
•podophyllotoxin cream Summary of Product Characteristics)
•9. Patients who have had topical steroids applied to the target area, or systemic steroids or other immunosuppressive agents, within 1 month prior to randomisation
•10. Patients enrolled in any other trial of an Investigational Medicinal Product, without the permission of the Chief Investigator
•11. Any clinical condition which the investigator considers would make the patient unsuitable for the trial, including immunodeficiency conditions

发起方

niversity College London (UK)