Genital herpes simplex virus (HSV)
infection, a
sexually transmitted disease (STD), is the commonest cause of ulcerative genital
infections among the young and adult population. The significant association of genital ulceration and transmission of human immunodeficiency virus (HIV) has been shown in many studies. To explore the potential efficacy of topical treatment of
genital herpes with
penciclovir cream, a randomized, double-blind, multicentre,
acyclovir-controlled Phase II clinical trial of
penciclovir 1% cream 5 times daily up to 7 days for suppression of
genital herpes was conducted in China. A total of 205 patients aged 20-59 years (mean age 36.0+/-8.8 years for
acyclovir and 34.8+/-8.4 years for
penciclovir) with a clinical diagnosis of
genital herpes were randomly allocated to one of the 2 parallel treatment groups and used for analysis. Clinical assessment were made before treatment and followed up at every visit during the study. Our results show that there was an encouraging improvement simultaneously in the 2 groups although no significant differences in clinical efficacy with respect to clinical cure rate, and times to healing, resolution of all symptoms, absence of
blisters, cessation of new
blisters, crusting, and loss of crust between
penciclovir and
acyclovir groups in terms of primary, non-primary and total patients were found. However a significantly shorter time to crusting was found in primary
penciclovir group when compared with primary
acyclovir group. Adverse experience was generally infrequent and mild, and was comparable in the 2 treatment groups. Based on these preliminary clinical findings, further evaluation of
penciclovir 3% cream for topical treatment of
genital herpes is planned.