SELF-TREATMENT USING 0.25-PERCENT-0.50-PERCENT PODOPHYLLOTOXIN-ETHANOL SOLUTIONS AGAINST PENILE CONDYLOMATA ACUMINATA - A PLACEBO-CONTROLLED COMPARATIVE-STUDY

Objective-To compare the efficacy of 0.50% and 0.25% podophyllotoxin p reparations against previously untreated penile warts. Design-The stud y was performed as a double-blind, placebo-controlled investigation on 57 males randomly allocated to one of three groups of 19 males in eac h, receiving either the placebo solution (70% ethanolic vehicle) or on e of the two podophyllotoxin preparations for 1-2 self-treatment cours es b.i.d. for three days, separated by a one-week drug-free interval. Setting-The STD out-patient clinic of the Department of Dermatovenereo logy at Southern Hospital of Stockholm, Sweden. Result-The placebo sol ution merely exerted a marginal influence on the warts while a primary cure was documented in 72% (13/18) and 81% (13/16) of altogether 34 e valuable men who treated their warts with 0.25% and 0.50% podophylloto xin, respectively. Follow-up investigation (range 5-23 weeks) was poss ible for 24 of 26 podophyllotoxin treated men who were primarily cured . Some degree of relapse occurred in nine of them (38%). Of these rela pses, warts occurred on previously untreated sites only in three cases (33%), and in another four (44%) relapse was associated with regrowth on treated sites as well as on new sites. When analysing the debulkin g potential of podophyllotoxin, it appeared that 0.25% podophyllotoxin eradicated 184 of originally 217 warts (85%); the corresponding figur e for 0.50% podophyllotoxin was as high as 130 of 135 lesions (96%). S ide effects were generally mild-moderate and well tolerated. Conclusio n-The results underscore the potential usefulness of low-dose podophyl lotoxin preparations as first-line chemotherapy of condylomata acumina ta for home-treatment. The efficacy from topical use of 0.25% podophyl lotoxin detected in the study is certainly of a magnitude signifying t hat podophyllotoxin concentrations lower than 0.50% deserve further in vestigation if the drug may be incorporated into alternative vehicles such as creams or ointments.