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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
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
The objective of the present Phase 3 clinical trial was to
also incorporates the preventive effect on ulcerative
evaluate the efficacy and safety of ME-609, which
treatment, the mean episode duration
lesions, was reduced by half in the ME-609 group
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
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
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
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 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
next HSL recurrence. Subject diary and daily clinical
visits were used for safety and efficacy data collection.
Spruance SL. The natural history of recurrent oral-facial herpes
Secondary herpes recurrences were recorded and viral
simplex virus infection. Seminars Dermatology 1992;11:200-20
Spruance SL and McKeough MB. Combination treatment with
famciclovir and a topical corticosteroid gel versus famciclovir alone
The primary study endpoint was prevention of ulcerative
for experimental ultraviolet radiation-induced herpes simplex labialis.
lesions (aborted episodes that did not progress beyond
A pilot study. J Infect Dis 2000;181:1906-1910.
Evans TG, Bernstein DI, Raborn GW, Harmenberg J Kowalski J, and
Spruance SL. Double-blind, randomized, placebo controlled study of
Secondary endpoints included ulcerative lesion:
topical 5% acyclovir-1% hydrocortisone cream (ME-609) for
i) episode duration to loss of hard crust
treatment of UV radiation-induced herpes labialis. Antimicrob Agts
The frequency of secondary herpes recurrences were
Spruance SL, Kriesel JD. Treatment of herpes simplex labialis.
5%, 7% and 7% in ME-609, acyclovir and placebo
iiii) cumulative lesion area, a global endpoint that
groups. 22%, 24% and 40% of subjects had positive viral
Hull C, McKeough M, Sebastian K, Kriesel J, Spruance S.
combines drug effects on lesion type, lesion duration and
cultures in ME-609, acyclovir and placebo groups. The
Valacyclovir and topical clobetasol gel for the episodic treatment of
lesion area and for which non-ulcerative (aborted)
frequency and nature of adverse events were similar
herpes labialis: a patient-initiated, double-blind, placebo-controlled
pilot trial. J Eur Acad Dermatol Venereol. 2009 Mar;23(3):263-7.
lesions were assigned a value of zero (5).
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