A SINGLE-BLIND STUDY OF PODOPHYLLOTOXIN CREAM 0.5-PERCENT AND PODOPHYLLOTOXIN SOLUTION 0.5-PERCENT IN MALE-PATIENTS WITH GENITAL WARTS

Objective-To evaluate the efficacy-safety ratio of a new topical podop hyllotoxin cream 0.5% compared with podophyllotoxin solution 0.5% (Con dyline) in male patients with genital warts. Methods-In an observer-bl inded controlled study a total of 136 and 133 wart lesions were treate d with podophyllotoxin in cream 0.5% and podophyllotoxin solution in 0 .5%, respectively. The preparations were applied twice daily for 3 day s, repeated with 4 days intervals for a minimum of two and a maximum o f four treatment cycles. Results-At the conclusion of the study (8 wee ks after completion of therapy) a significant reduction in mean wart a rea was observed in both the cream group (87.7, SD 8.4 to 20.6, SD 2.7 ) and in the solution group (92.3, SD 7.5 to 21.5, SD 2.8) (p < 0.01). At the same time all treated warts had completely cleared in 63% of p atients in both study groups. Mild to moderate side effects occurred t o the same extent in both podophyllotoxin cream and podophyllotoxin so lution recipients. Conclusion-We conclude that podophyllotoxin 0.5% ad ministered in a cream formulation does not give additional clinical be nefits when compared with podophyllotoxin solution 0.5% in male patien ts with external genital warts.