Acyclovir is used locally or systemically to treat
cold sore and totally have no side effect. However, this antiviral drug is not suitable for some people. The main aim of this study was to prepare and characterize
shallomin liposomal hydrogel formulation and evaluation and comparison of dermal efficacy of this new formulation with
acyclovir ointment on cold sores. Thin-Film Hydration was used to prepare
liposome consisting of lecithin and cholesterol (molar ratio: ۱:۱). Morphology, size analysis and
liposome encapsulation efficiency were determined. For preparation of hydrogel, Hydroxyethyl cellulose (HEC) was used. In vitro Skin permeation assay through abdominal region skin of male wistar rat was also determined. After preparing liposomal
shallomin ۱% in hydrogel a randomized controlled trial was performed on three groups (۱۵ students in each groups) who showed
cold sore within ۲۴ hours. Liposomal
shallomin gel,
acyclovir and placebo was used every ۶ hours for the first, second and third groups, respectively. The size of liposomal
shallomin particles were ۱۳۹±۳۱.۸ nm whereas polydispersity index values were ۰.۲۱۹ ± ۰.۰۱. The TEM images showed that the shape of particles was spherical and any aggregation or fusion were not seen. Furthermore, the particle size diameter was < ۱۵۰ nm. The encapsulation capacity with the liposomes was approximately calculated ۸۲.۷%. The
cold sore and tingling was disappeared in liposomal
shallomin gel treated group within ۰-۱۲ hours in ۱۲ cases (۸۰%) and within ۱۲-۲۴ hours in ۲ cases. In the
acyclovir treated group, skin was cleared from
cold sore in ۸ cases (۵۳%) within ۲۴-۴۸ hours after using drug. Regarding the obtained results, the liposomal
shallomin gel caused a significant improvement in the removing cold sores within ۱۲ hours related to
acyclovir (P=۰.۰۰۱). Because mucoidal properties of hydrogel can facilitate adhesion between the
shallomin and skin membrane, which extend keeping of
shallomin at the site of administration and enhancing drug permeation so, liposomal
shallomin gel is more effective treatment than
shallomin extract and
acyclovir with fewer side effects for cold sores treatment.