TOPICAL 0.3-PERCENT AND 0.5-PERCENT PODOPHYLLOTOXIN CREAM FOR SELF-TREATMENT OF MOLLUSCUM CONTAGIOSUM IN MALES - A PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY
Ta. Syed et al., TOPICAL 0.3-PERCENT AND 0.5-PERCENT PODOPHYLLOTOXIN CREAM FOR SELF-TREATMENT OF MOLLUSCUM CONTAGIOSUM IN MALES - A PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY, Dermatology, 189(1), 1994, pp. 65-68
Background: Molluscum contagiosum is generally a self-limiting benign
skin disease that affects mostly children and young adults. Objective:
The purpose of this multicenter, double-blind, placebo-controlled stu
dy was to compare the clinical efficacy and tolerance of 0.3% and 0.5%
podophyllotoxin in a hydrophilic cream base to cure molluscum contagi
osum in Asian males. Methods: Preselected patients (n = 150), age rang
e 10-26 years (mean: 15.4), harboring 1,125 lesions (mean: 7.5), with
size ranging from 2 to 8 mm in diameter (mean spot size 3.2 mm) and bi
opsy-proven diagnosis of molluscum contagiosum, were randomly allocate
d to three parallel groups. Twenty-four (16%) patients had atopic derm
atitis. Patients self-administered placebo, 0.3% or 0.5% podophyllotox
in cream, twice daily for 3 consecutive days, and if total elimination
was not achieved with one trial (6 topical applications), the same tr
eatment was extended to 3 more weeks (24 topical applications in 4 wee
ks). The duration of the study was 12 weeks with 6 months (on monthly
basis) follow-up. By the end of the treatment 80 patients (52, 92 and
16% patients in the 0.3%, 0.5% and the placebo groups, respectively) w
ere evaluated as completely cured. During the treatment 92 patients (6
1.3%) did not complain of any allergic or localized adverse symptoms.
Tolerable moderate to mild frequent side effects were pruritus (20.6%)
and erythema (18%), with no dropouts. No recurrence was seen after 9
months of follow-up. Response to the trial medications appeared to be
directly proportional to the concentration of podophyllotoxin (p < 0.0
01). Self-medication was well accepted by all the patients. It was con
cluded that the 0.5% podophyllotoxin cream preparation was more effica
cious than the 0.3% incorporation (p < 0.001) and can be considered a
safe, home-based first line of therapy to cure molluscum contagiosum.