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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
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
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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