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

Not Applicable

Completed

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

• Registration Number: ISRCTN32729817
• Lead Sponsor: niversity College London (UK)

Brief Summary

2018 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30400777 2020 results in https://pubmed.ncbi.nlm.nih.gov/32975189/ (added 28/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-25
• Study Completion: 2017-03-31
• Last Update Posted: 12 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 503

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wart clearance within 16 weeks of starting treatment and remaining wart-free between 16 and 48 weeks