A clinical evaluation of a novel liposomal carrier for acyclovir in the topical treatment of recurrent herpes labialis,☆☆

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Abstract

In a 2-armed, double-blind, randomized clinical study, the efficacy in the treatment of recurrent herpes labialis of 5% acyclovir in a novel liposomal carrier (ethosome) was evaluated in comparison with that of a commercial 5% acyclovir cream (Zovirax cream) and that of a drug-free vehicle. Data were based on 61 herpetic episodes in 40 subjects. In a crossover arm in which the 2 active preparations were compared, the time to crusting of lesions was significantly shorter (P < .025) with the ethosomal acyclovir (1.8 days) than with the cream (3.5 days). Time to loss of crust was also significantly shorter (4.2 vs 5.9 days; P < .05). In a parallel arm in which all 3 preparations were compared, the time to crusting with the ethosomal acyclovir (1.6 days) was significantly shorter than the time with the acyclovir cream (4.3 days; P < .02) and the time with the drug-free vehicle (4.8 days; P < .005); in this arm, the shorter time to loss of crust for the ethosome (3.5 days), in comparison with the times for the cream (6.4 days) and the drug-free vehicle (6.1 days), did not reach statistical significance. Approximately 30% of all episodes treated with the ethosome were clinically abortive; this compared with 10% of those treated with the cream or the drug-free vehicle. No adverse effects were reported, other than minor burning sensations at the application site that lasted a few seconds after application and were evenly distributed between the investigated preparations. This pilot study suggests the improved clinical efficacy of the new liposomal preparation in comparison with Zovirax cream in the treatment of recurrent herpes labialis. (Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1999;87:700-5)

Section snippets

Subject population

Subjects with histories of RHL (as diagnosed at our clinic by an oral medicine specialist) who had no major underlying disease, experienced 3 or more recurrences per year, and were at least 18 years of age were considered eligible to participate in the study. Subjects were excluded if they were pregnant, lactating, immunocompromised, or receiving immunosuppressive or antiviral medications. All participants gave written informed consent.

Materials

The new ethosomal 5%-acyclovir preparation (EA) and a

Characterization of subject population

Fifty-eight participants were enrolled, having met the inclusion criteria and signed informed consent forms. Thirteen participants were inactive throughout the trial period, experiencing no assessable episodes. Five participants were dropped: 1 because of pregnancy, 1 because of overseas travel, 1 because of discontent with the treatment randomly assigned for the first episode (V), and 2 (of whom one had been assigned to receive EA and the other to receive V) because of noncompliance with the

DISCUSSION

Inadequate skin absorption was proposed as a major contributor to the modest clinical efficacy of previously studied topical ACV formulations in the treatment of RHL. The ethosome, designed as a novel carrier for enhanced topical and transdermal delivery of drugs, appears to improve the clinical efficacy of ACV in treating RHL.

The results of the present clinical study suggest the improved clinical efficacy of liposomal ACV, as compared to ZC. The major clinical parameter measured in the study,

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    Topical acyclovir in the management of herpes labialis

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  • Cited by (0)

    Reprint requests: Elka Touitou, PhD, Department of Pharmaceutics, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, POB 12065, Jerusalem 91120, Israel

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