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Antimicrobial Agents and Chemotherapy, June 2002, p. 1870-1874, Vol. 46, No. 6
0066-4804/02/$04.00+0     DOI: 10.1128/AAC.46.6.1870-1874.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Double-Blind, Randomized, Placebo-Controlled Study of Topical 5% Acyclovir-1% Hydrocortisone Cream (ME-609) for Treatment of UV Radiation-Induced Herpes Labialis

T. G. Evans,^1* D. I. Bernstein,² G. W. Raborn,³ J. Harmenberg,^4,5 J. Kowalski,^4,5 and S. L. Spruance⁶

University of Rochester, Rochester, New York,¹ Children's Hospital Research Foundation, Cincinnati, Ohio,² University of Alberta, Edmonton, Alberta, Canada,³ Medivir AB, Huddinge,⁴ Karolinska Institute, Stockholm, Sweden,⁵ University of Utah, Salt Lake City, Utah⁶

Received 12 November 2001/ Returned for modification 4 January 2002/ Accepted 14 March 2002

Immunopathology is recognized as an important component of infectious disease manifestations, and corticosteroids have been used as an adjunct to antimicrobial therapy for a variety of conditions. Antiviral therapy of herpes labialis has been shown to result in only a small reduction in the time to healing and the duration of pain. To determine if topical application of a combination product containing 5% acyclovir and 1% hydrocortisone (ME-609) could provide benefit to herpes labialis patients, 380 immunocompetent adults with a history of herpes labialis were exposed to experimental UV radiation (UVR) to induce a recurrence. On day 2, just before the appearance of the majority of lesions ("delayed" lesions), subjects were randomized to receive active medication or vehicle control six times per day for 5 days. Overall, 120 of 380 patients developed delayed classical lesions, of whom 50 of 190 (26%) had been treated with ME-609 and 70 of 190 (37%) had received placebo (a reduction of 29% [P = 0.02]). Healing time, measured as the time to normal skin, was reduced by treatment with ME-609 (9.0 days for treated patients versus 10.1 days for the controls [P = 0.04]). There was a trend toward a reduction in the maximum lesion size in the ME-609 recipients compared to that in the controls (43 versus 60 mm², respectively [P = 0.07]). The treatment had no effect on lesion pain, but ME-609 treatment reduced the number of patients with moderate or severe tenderness. Compared to treatment with a placebo, treatment with the combination antiviral-immunomodulatory cream provided benefit to patients with experimental UVR-induced herpes labialis, reducing classical lesion incidence, healing time, lesion size, and lesion tenderness. ME-609 is a novel product that merits further evaluation as a treatment for cold sores.

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* Corresponding author. Present address: Division of Infectious Diseases, University of California, Davis, 4150 V St., PSSB 500, Sacramento, CA. Phone: (916) 734-3741. Fax: (916) 734-7766. E-mail: tgevans{at}ucdavis.edu.

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Antimicrobial Agents and Chemotherapy, June 2002, p. 1870-1874, Vol. 46, No. 6
0066-4804/02/$04.00+0     DOI: 10.1128/AAC.46.6.1870-1874.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

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