TOPICAL 0.3-PERCENT AND 0.5-PERCENT PODOPHYLLOTOXIN CREAM FOR SELF-TREATMENT OF CONDYLOMATA ACUMINATA IN WOMEN - A PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY
Ta. Syed et al., TOPICAL 0.3-PERCENT AND 0.5-PERCENT PODOPHYLLOTOXIN CREAM FOR SELF-TREATMENT OF CONDYLOMATA ACUMINATA IN WOMEN - A PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY, Dermatology, 189(2), 1994, pp. 142-145
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.