Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial.
BACKGROUND
Prior pilot studies support the use of antiviral medications with topical corticosteroids for herpes simplex labialis (HSL). ME-609 (Xerese, Xerclear) is a combination of 5% acyclovir and 1% hydrocortisone developed for the topical treatment of HSL.


OBJECTIVE
The primary study end point was the prevention of ulcerative HSL lesions.


METHODS
In all, 2437 patients with a history of HSL were randomized to self-initiate treatment with ME-609, 5% acyclovir in ME-609 vehicle, or ME-609 vehicle (placebo) at the earliest sign of a cold sore recurrence. Cream was applied 5 times/d for 5 days. A total of 1443 patients experienced a recurrence and initiated treatment with ME-609 (n = 601), acyclovir (n = 610), or placebo (n = 232).


RESULTS
Of patients receiving ME-609, 42% did not develop an ulcerative lesion compared with 35% of patients receiving acyclovir in ME-609 vehicle (P = .014) and 26% of patients receiving placebo (P < .0001). In patients with ulcerative lesions, healing times were reduced in the ME-609 and acyclovir groups compared with placebo (P < .01 for both). The cumulative lesion area for all lesions was reduced 50% in patients receiving ME-609 compared with the placebo group (P < .0001). There were no differences among groups in the number of patients with positive herpes simplex virus cultures. The side-effect profile was similar among treatments.


CONCLUSIONS
The study did not contain a group treated with a topical corticosteroid alone.


CONCLUSIONS
ME-609 prevented progression of cold sores to ulcerative lesions and significantly reduced the cumulative lesion area compared with acyclovir and placebo. ME-609 treatment offers additional therapeutic benefit compared with therapy with topical acyclovir alone.
Hull
Christopher M
CM
Department of Dermatology, School of Medicine, University of Utah, Salt Lake City, Utah 84132-2409, USA. Christopher.Hull@hsc.utah.edu
Harmenberg
Johan
J
Arlander
Eva
E
Aoki
Fred
F
Bring
Johan
J
Darpö
Börje
B
Levin
Myron J
MJ
Tyring
Stephen
S
Spruance
Spotswood L
SL
D000212:Acyclovir / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006560:Herpes Labialis / Q000188:drug therapy* / Q000473:pathology / Q000517:prevention & control*; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010919:Placebos; D055502:Secondary Prevention; D012646:Self Administration; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000998:Antiviral Agents; D004338:Drug Combinations; C558464:ME 609; D010919:Placebos; D006854:Hydrocortisone; D000212:Acyclovir