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.