title: Double-blind, randomized, placebo-controlled study of topical 5% acyclovir-1% hydrocortisone cream (ME-609) for treatment of UV radiation-induced herpes labialis.
abstract: 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 mm(2), 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.
authors.affiliation: University of Rochester, Rochester, New York, USA. tgevans@ucdavis.edu
authors.forename: T G
authors.initials: TG
authors.lastname: Evans
authors.forename: D I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: G W
authors.initials: GW
authors.lastname: Raborn
authors.forename: J
authors.initials: J
authors.lastname: Harmenberg
authors.forename: J
authors.initials: J
authors.lastname: Kowalski
authors.forename: S L
authors.initials: SL
authors.lastname: Spruance
mesh_terms: D000212:Acyclovir / Q000008:administration & dosage / Q000627:therapeutic use*; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006560:Herpes Labialis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D055502:Secondary Prevention; D014466:Ultraviolet Rays
chemical_list: D000893:Anti-Inflammatory Agents; D000998:Antiviral Agents; D004338:Drug Combinations; D009824:Ointments; D006854:Hydrocortisone; D000212:Acyclovir