Ta. Syed et al., TREATMENT OF GENITAL HERPES IN MALES WITH IMIQUIMOD 1-PERCENT CREAM -A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY, Clinical drug investigation, 16(3), 1998, pp. 187-191
Objective: The aim of this randomised, double-blind, placebo-controlle
d study was to examine the clinical significance, efficacy and tolerab
ility of imiquimod 1% cream to manage patients exposed to first episod
es of genital herpes. Patients: Male patients (n = 60), ranging in age
between 18 and 50 years (mean 25.7 years), presenting for <6 days (me
an 4.4 days) with culture-confirmed diagnosis of genital herpes, and b
earing a total of 696 lesions (mean 11.6 lesions/patient), entered the
study and were randomised to receive a preceded 40g tube and instruct
ions on how to apply the trial medication to their lesions twice for 5
consecutive days per week. Results: A marked clinical benefit from se
lf-application of imiquimod 1% cream was demonstrated, resulting in bo
th significantly shorter mean duration of healing than with the placeb
o (5.2 vs 14 days; p < 0.001) and more healed patients [23 of 30 (76.7
%) vs 2 of 30 (6.7%); p < 0.0001]. Of the 60 patients, 54 (90%) report
ed no drug-related adverse effects. Two patients in the imiquimod grou
p reported non-objective mild burning sensation and four experienced a
transitory increase in their body temperature (>38 degrees C) accompa
nied by mild headache and malaise; however, such indications were not
severe enough to cause discontinuation of the treatment, and resolved
within 24 hours. Treatment was well tolerated by all the patients, wit
h no dropouts. Among 25 healed patients, four had a relapse after 9 mo
nths. Conclusion: Although the analogue of imiquimod 1% cream demonstr
ated mild to moderate subjective adverse effects, it was significantly
more effective than placebo in treating patients with a first episode
of genital herpes. Further clinical studies appear warranted.