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A multi-centre, randomised, double-blind, placebo-controlled study of cryotherapy versus cryotherapy and podophyllotoxin cream as treatment for external anogenital warts.
  1. Richard Gilson (rgilson{at}gum.ucl.ac.uk)
  1. UCL Medical School, United Kingdom
    1. Jonathan Ross (jonathan.ross{at}hobtpct.nhs.uk)
    1. Whittal Street Clinic, United Kingdom
      1. Raymond Maw (raymond.maw{at}belfasttrust.hscni.net)
      1. Belfast Royal Infirmary, United Kingdom
        1. David Rowen (david.rowen{at}scpct.nhs.uk)
        1. Royal South Hampshire Hospital, United Kingdom
          1. Christopher Sonnex (christopher.sonnex{at}addenbrookes.nhs.uk)
          1. Addenbrookes Hospital, United Kingdom
            1. Charles Lacey (charles.lacey{at}hyms.ac.uk)
            1. Hull York Medical School, United Kingdom

              Abstract

              Objectives: To compare the efficacy and safety of combination therapy with cryotherapy and podophyllotoxin 0.15% cream versus cryotherapy alone in the treatment of anogenital warts.

              Methods: A randomised, double-blind, multi-centre controlled trial. Patients received podophyllotoxin cream or placebo twice daily for 3 days/week for up to 4 weeks, with weekly cryotherapy continued to week 12 if required. Further treatment from week 12-24 was discretionary. Patients were stratified by sex and history of warts. HIV-positivity, warts treated in the past 4 months, or warts with a combined area of <10mm2 were exclusion criteria. Primary endpoints were clearance at week 4 and 12.

              Results: 70 patients per group were randomised and started treatment; 101 first-episode warts, 91 male. No treatment-related serious adverse events were reported. Follow-up at week 12 was 85%. By intention-to-treat analysis, clearances at 4 and 12 weeks were higher in the combination group (60.0% and 60.0% respectively) than with cryotherapy alone (45.7%, 45.7%) although not statistically significant (relative risk 1.31; 95% CI 0.95, 1.81). By week 24 there was no difference between the groups (68.6% and 64.3% respectively, RR 1.07; CI 0.84, 1.35). At week 4, wart clearance was higher in men (p=0.001) and those with a past history of warts (p=0.009), but these differences were not detected at week 12. There was some evidence for a higher relapse rate in the group receiving cryotherapy alone.

              Conclusions: Initial combination therapy with podophyllotoxin/cryotherapy was well tolerated and may have resulted in earlier clearance in some patients, compared to cryotherapy alone, however overall differences in clearance rates were not statistically significant.

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