TOPICAL TREATMENT OF VENEREAL WARTS - A COMPARATIVE OPEN STUDY OF PODOPHYLLOTOXIN CREAM VERSUS SOLUTION

Podophyllotoxin solution (0.5%) is licensed for use in the treatment o f condylomata acuminata (genital warts) in men in a number of European countries. In some countries, approval also extends to treatment of g enital warts in women. This controlled randomized prospective study ev aluated the efficacy and safety of a cream formulation of podophylloto xin at 2 concentrations (0.15% and 0.3%), using 0.5% podophyllotoxin s olution 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' calcu lated at each clinic visit. The mean 'response rates' in the male pati ent 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 'r esponse 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 st atistically significant differences between the 3 treatments with rega rd to both efficacy and safety. This was true for both the male and fe male patient groups.