Episodic Treatment with Topical ACV/Hydrocortisone Prevents Cold Sores: A Randomized, Double-Blind, Patient-Initiated Clinical Trial C. HULL1, J. HARMENBERG2, E. ARLANDER3, F. AOKI4, B. DARPO3, M. LEVIN5, S. TYRING6, S. L. SPRUANCE1 1Univ. of Utah Sch. of Med., Salt Lake City, UT, 2Karolinska Inst., Stockholm, Sweden, 3Medivir, Huddinge, Sweden, 4Univ. of Manitoba, Winnipeg, Canada, 5Univ. of Colorado Sch. of Med., Aurora, CO, 6Univ. of Texas Health.Sci. Ctr., Houston, TX Background Conclusions
The proportion of subjects with non-ulcerative
Figure 1. The frequency of aborted lesions in relation to stage
The pathogenesis of recurrent herpes simplex labialis
• ME-609 prevented ulcerated lesions in subjects with
(HSL) involves both the destruction of cells by the virus,
recurrences (aborted lesions) was higher in the ME-
recurrent HSL compared to both topical acyclovir and
609 group (254/601 = 42%) compared to the acyclovir
and the host immune response. Current approved
antiviral medications provide modest reduction of lesion
(216/610 = 35%; p=0.014) and the placebo groups
• In subjects who developed an ulcerative lesion
healing time through limitation of the virus replication, but
(60/232 = 26%; p<0.0001), independent of at what
despite treatment, the healing time was reduced by
has little impact on the associated inflammatory cascade
treatment stage subjects started treatment (Figure 1).
ME-609 to the same extent as acyclovir alone.
• The cumulative lesion area, a global endpoint that
In subjects who developed an ulcerative lesion despite
Prodrome
The objective of the present Phase 3 clinical trial was to
also incorporates the preventive effect on ulcerative
Erythema
evaluate the efficacy and safety of ME-609, which
treatment, the mean episode duration and lesion
lesions, was reduced by half in the ME-609 group
healing time were significantly shorter in ME-609 treated
contains 5% acyclovir and 1% hydrocortisone in a
compared to placebo and was significantly smaller than
subjects than in placebo subjects (Table 1).
proprietary formulation in patients with recurrent HSL.
in both the acyclovir and placebo groups.
The maximum lesi Materials and Methods on area was smallest in the ME-609
ME-609 was approved for marketing in United States
group but the differences were not statistically significant
on July 31, 2009 with the following indication:
This randomized, double blinded study was conducted at
(Table 1).For the cumulative lesion area was reduced acyclovir in
51 sites in US and 4 sites in Canada from July 2006 to
by half in the ME-609 group compared to placebo and
“ME-609 is indicated for the early treatment of recurrent Background
December 2007. Written informed consent was obtained
was significantly smaller than in both the acyclovir and
herpes labialis (cold sores) to reduce the
from all study subjects and an Institutional Review Board
placebo groups (Table 1 and Figure 2). likelihood of ulcerative cold sores and to shorten the
Figure 2. The mean cumulative lesion size.
approved the study protocol. Subjects at least 18 years
of age with a history of at least 3 HSL episodes in the
past year were randomized to ME-609 (n=1018),
Acyclovir in
acyclovir in the ME-609 vehicle (n=1033) or placebo (the
Subjects were asked to start treatment at home 5 times
daily for 5 days at the earliest sign/symptoms of their
References
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visits were used for safety and efficacy data collection.
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