A Double-Blind, Randomized Trial of 0.5% Podofilox and Placebo for the Treatment of Genital Warts in Women

Patient-applied formulations of 0.5% podofilox (podophyllotoxin) were evaluated for the treatment of external genital warts in a double-blind, placebo-controlled study. Seventytwo women were enrolled and, using a randomized, computer-generated list, assigned to receive either active drug or placebo in a 2:1 ratio. Patients were instructed to apply the medication to their external warts twice each day for 3 consecutive days, followed by 4 days without treatment. This cycle was repeated at weekly intervals for a maximum of 4 weeks (and a minimum of 2 weeks). Patients were evaluated weekly for the first month and then at weeks 6 and 10. The number of warts present was recorded and the overall improvement was assessed. The treated area was examined, the patients were questioned about any adverse effects, and standard hematologic/biochemical studies were conducted. The final results showed that podofilox cleared 74% of the total wart count, compared with an 18% regression in the placebo group (P