Topical treatment of venereal warts: a comparative open study of podophyllotoxin cream versus solution

Abstract

Podophyllotoxin solution 0.5 is licensed for use in the treatment of condylomata acuminata genital warts in men in a number of European countries. In some countries, approval also extends to treatment of genital warts in women. This controlled randomized prospective study evaluated the efficacy and safety of a cream formulation of podophyllotoxin at 2 concentrations 0.15 and 0.3 , using 0.5 podophyllotoxin solution as a reference treatment. Two separate studies were initiated, to assess the 3 treatment groups in a male patients, and b female patients. Statistical evaluation was based on a 'response rate' calculated at each clinic visit. The mean 'response rates' in the male patient study at 4 weeks were 75.1 , 79.0 and 85.6 in the 0.15 cream, 0.3 cream and 0.5 solution groups, respectively. The corresponding 'response rates' for the female patient study were 86.2 , 92.6 , and 93.1 , respectively. The relapse rates for both male and female patients were 6.0 in the 0.15 cream group, 8.6 in the 0.3 cream group and 8.6 in the 0.5 solution group. The results show that there were no statistically significant differences between the 3 treatments with regard to both efficacy and safety. This was true for both the male and female patient groups.