Topical treatment of penile condylomata acuminata with podophyllotoxin 0.3% solution, 0.3% cream and 0.15% cream. A comparative open study.

The purpose of this comparative open study was to determine the clinical efficacy of 0.3% podophyllotoxin both in 70% ethanolic solution and cream preparations on genital warts. Three parallel trial preparations, 0.3% solution, 0.3% and 0.15% cream, were randomly allocated to 60 circumcised Asian males (mean age 19.5 years), with the diagnosis of genital condyloma. Patients applied the trial preparation twice a day for 3 consecutive days. If total elimination was not achieved with one trial, it was extended to 3 similar cycles, in total of 4 weeks duration. Response was calculated with a response rate formula. After 3 weeks of treatment all the patients in the 0.3% solution group were evaluated as cured, with mild localized erythema and burning sensation. In the 0.3% cream preparation group, 75% of the patients were cured, and the remaining 25% were found to be cured after 4 treatments. In the 0.15% cream preparation group, 70% of the patients were evaluated as completely cured after 4 weeks. Non-objective, moderate to mild localized adverse symptoms were reported by both the active cream groups. Three of 54 patients (90%) with complete cure showed relapses after 16 weeks. It was concluded that 0.3% podophyllotoxin is more efficacious in ethanolic solution than in cream preparations.