Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology
A clinical evaluation of a novel liposomal carrier for acyclovir in the topical treatment of recurrent herpes labialis☆,☆☆
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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Cited by (0)
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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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1079-2104/99/$8.00 + 0 7/13/97861