A novel drug delivery system using acyclovir nanofiber patch for topical treatment of recurrent herpes labialis: A randomized clinical trial

Abstract

OBJECTIVES: Topical treatment with acyclovir cream has shown low efficacy in recent studies. Nano drug delivery systems, have received much attention in recent decades. The aim of this study was to compare the efficacy of acyclovir nanofiber patch with acyclovir cream. MATERIAL AND METHODS: In this double-blind three-armed randomized clinical trial, a total of 60 patients with recurrent labial herpes, were randomly divided into three groups, each consisting of 20. The patients in the first, second, and third groups were treated with acyclovir nanofiber patch, placebo nanofiber patch, and acyclovir cream, respectively. A numerical scale was used by the patients to record the self-reported symptoms. Symptoms score, crusting time and healing time were assessed by the clinician. Kruskal-Wallis test was used to compare the symptoms between the three groups, a survival test was also performed to evaluate the crusting and healing time. Data were analyzed in SPSS V22 at P-value < 0.05. RESULTS: The mean scores of symptoms at baseline were 1.6, 1.5, and 1.4 in the first, second, and third groups, respectively. The symptoms were not significantly different between the three groups on different treatment days. The mean crusting time was 2.3, 2.4, and 2.6 days in the three groups, and the mean healing time was 7.4, 7.2, and 7.7 days, respectively. Crusting time and healing time were not significantly different between the three groups. CONCLUSIONS: Acyclovir nanofiber patches are recommended for accelerating symptom relief in recurrent labial herpes, however, they are not effective in shortening the crusting or healing time. CLINICAL TRIAL REGISTRATION NUMBER: IRCT20141124020073N2. Registered in: Iranian Registry of Clinical Trials (www.irct.ir).