Extract

Background and study aims Genital warts are a very common sexually transmitted disease and are caused in over 90% of cases by human papillomavirus (HPV) types 6 or 11. Podophyllotoxin (as a cream or solution) and imiquimod cream are the most frequently used topical treatments for genital warts, but they have never been adequately compared to determine their relative effectiveness with respect to the clearance or recurrence rate. A vaccine is available to prevent HPV 6 and 11 (as well as HPV 16 and 18, the viruses that cause most cervical cancer), but it is not known whether it will increase the rate of clearance of genital warts if it is given at the same time as topical treatment, or whether it can prevent recurrences. The aim of this study is to find out whether imiquimod or podophyllotoxin is more effective at clearing and preventing recurrence of genital warts, and whether the addition of HPV vaccination provides additional benefits. Who can participate? Patients aged 18 or over with genital warts What does the study involve? Participants are randomly allocated to be treated with either imiquimod cream or podophyllotoxin cream, and to be treated with either a course of quadrivalent HPV vaccine (active against HPV types 6/11/16/18) or a placebo (dummy injection). This results in four treatment groups: imiquimod cream plus HPV vaccine; podophyllotoxin cream plus HPV vaccine; imiquimod cream plus placebo vaccine; and podophyllotoxin cream plus placebo vaccine. Successful treatment is defined as clearance of warts after 16 weeks and no relapse between 16 and 48 weeks. The study also compares the time taken for warts to be cleared with each treatment, the number of patients switching treatment because of non-response to treatment or side-effects, and the patients’ quality of life. An analysis is also conducted to compare the cost effectiveness of each treatment. Imiquimod is currently more expensive than podophyllotoxin (although the cost difference is expected to reduce). The economic benefit of HPV vaccination is also studied. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? University College London (UK) When is the study starting and how long is it expected to run for? June 2014 to March 2017 Who is funding the study? Health Technology Assessment Programme (UK) Who is the main contact? Jade Meadows [email protected]

Inclusion criteria

• Topic: Infectious diseases and microbiology; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology

Links

• isrctn
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