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.