Topic: Infectious diseases and microbiology
Conditions
Interventions
The trial will follow participants for 48 weeks (6 visits). They will be randomly assigned to one of the creams (imiquimod 5% or podophyllotoxin 0.15%). Patients will know which cream they have been g
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wart clearance within 16 weeks of starting treatment and remaining wart-free between 16 and 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion wart-free at the end of the assigned treatment course; Timepoint(s): 4 or 16 weeks 2. Proportion experiencing wart recurrence/relapse after complete wart clearance; Timepoint(s): Up to 48 weeks 3. Time from complete wart clearance to recurrence/relapse; Timepoint(s): Up to 48 weeks 4. Adverse events; Timepoint(s): As required 5. Health-related quality of life, as measured by the Area Under the Curve for EQ-5D; Timepoint(s): At all visits 6. Symptom scores; Timepoint(s): At all review of treatment visits 7. Total costs of treatment including prescribed agents and clinic visits; Timepoint(s): 48 weeks 8. Proportion wart-free at 16 weeks, with use of additional treatment as required; Timepoint(s): 16 weeks 9. Quantity of additional treatment required to achieve clearance by 16 weeks; Timepoint(s): 16 weeks 10. Proportion wart-free at 24 weeks; Timepoint(s): 24 weeks 11. Proportion wart-free at 24 weeks with use of additional treatment as required; Timepoint(s): 24 weeks 12. Qantitiy of additional treatment required to achieve clearance by 24 weeks; Timepoint(s): 24 weeks 13. Proportion experiencing wart recurrence/relapse at 48 weeks after wart clearance at 24 weeks; Timepoint(s): 24, 48 weeks 14. Proportion experiencing complete wart clearance; Timepoint(s): 48 weeks 15. Time to complete wart clearance; Timepoint(s): Point of wart clearance | — |
Countries
United Kingdom
Outcome results
None listed