TOPICAL 0.3-PERCENT AND 0.5-PERCENT PODOPHYLLOTOXIN CREAM FOR SELF-TREATMENT OF CONDYLOMATA ACUMINATA IN WOMEN - A PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY

Background: Genital warts are a well-recognized clinical entity and a disease of great antiquity that differ from skin warts both histologic ally and antigenically. It is a common sexually transmitted disease of high prevalence all over the world. Women are more likely to be unawa re of such warts because it is harder for them to examine their genita lia. Objective: The purpose of this multicenter, double-blind, placebo -controlled study was to compare the clinical efficacy and tolerance o f 0.3% and 0.5% podophyllotoxin in a cream emulsion (castor oil, BP as vehicle) to cure genital condylomata in women. Methods: Preselected ( n = 80) Asian females (mean age 23.6 years), harboring 544 warts (mean 6.8 in number), ranging from 1 to 9 mm in size (mean 2.1 mm) with bio psy-proven diagnosis of condylomata acuminata were randomly allocated to three groups (30 + 30 + 20). At home the patients applied the given trial medication themselves (using the finger) twice a day, for 3 con secutive days per week, and if not cured the same course was extended to 3 more weeks, in total 24 topical applications for 4 weeks. The pat ients were examined on a weekly basis, and a total regression of warts (biopsy-proven) was evaluated as complete cure. Results: By the end o f the study, the placebo group (20 patients, bearing 124 warts) did no t show any regression or clinical efficacy, while 41/60 patients (68.3 %) and 349/420 warts (83%) were cured in the 0.3% and 0.5% treatment g roups (placebo vs. active groups p < 0.001). Patients using the 0.5% a ctive medication had substantially more eliminated warts (205/349, 95. 8%) than the 0.3% group (70%). Localized adverse symptoms were mild to moderate and were well tolerated by the patients with no dropout. For ty-three patients (53.8%) did not show any adverse reaction. The most frequent adverse symptoms were tenderness (23/80, 28.8%) and burning s ensation (14/80, 17.5%). Among 41/80 (51.25%) cured patients 4 had a r elapse after 16 weeks. Conclusion: Along with mild, tolerable side eff ects the study demonstrates that 0.5% podophyllotoxin cream is more ef ficacious than 0.3% (p < 0.01) and can be considered as a reliable hom e-based treatment.