Topical application of penciclovir cream for the treatment of herpes simplex facialis/labialis: a randomized, double-blind, multicentre, aciclovir-controlled trial

BACKGROUND: Herpes simplex facialis/labialis (HSFL) is a common infectious skin disorder, caused mainly by herpes simplex virus (HSV) type 1, for which the topical application of a cream containing an antiviral agent for treatment of the disease has been widely utilized. OBJECTIVE: To explore the efficacy of the topical application of 1% penciclovir cream in the treatment of HSFL, and to compare its efficacy and safety with 3% aciclovir cream. METHODS: A total of 248 patients with a diagnosis of HSFL were randomly allocated to one of the two treatment groups (n = 124 each), using stratified randomization based on a table of random numbers. Before treatment (day 0) and at every visit (days 3, 5 and 7) during the study, the sign and symptom scores were recorded by the same doctor. RESULTS: Excluding 23 patients (10 in the penciclovir and 13 in the aciclovir groups), 225 completed the study, and no severe adverse events were noted with any of the treatment regimens. Results show that an encouraging improvement in the clinical course was found simultaneously for patients with each episode type and each treatment assignment. There were no significant differences in terms of efficacy endpoint, clinical cure rate, and safety between the two treatment arms, but there was a trend towards a shorter time to resolution of all symptoms, cessation of new blisters, and loss of crust (p less than or equal to0.08) in penciclovir-treated primary patients. In addition, the clinical scores in penciclovir-treated primary patients were significantly lower than those in the respective aciclovir-treated patients on treatment day 5 (p < 0.01) and day 7 (p < 0.05). CONCLUSION: Topical 1% penciclovir cream is as convenient and as effective as 3% aciclovir cream for the treatment of HSFL. Penciclovir cream may provide a good topical alternative to other types of therapy in the future.