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document
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 . OBJECTIVES 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 . LIMITATIONS 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 .
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Intervention_Pharmacological
ME-609
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Intervention_Pharmacological
ME-609 ( Xerese , Xerclear )
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Intervention_Pharmacological
acyclovir
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Intervention_Pharmacological
hydrocortisone
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Intervention_Pharmacological
randomized to self-initiate treatment with ME-609
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Intervention_Pharmacological
5 % acyclovir in ME-609 vehicle
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Intervention_Physical
ME-609 vehicle ( placebo )
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Intervention_Pharmacological
Cream was applied 5 times/d for 5 days
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Intervention_Pharmacological
ME-609
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Intervention_Pharmacological
acyclovir
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Intervention_Control
placebo
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Intervention_Pharmacological
acyclovir in ME-609 vehicle
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Outcome_Physical
frequency of ulcerative lesions :
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Outcome_Physical
ulcerative HSL lesions .
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Outcome_Physical
a recurrence
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Outcome_Physical
ulcerative lesion
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Outcome_Other
healing times
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Outcome_Physical
cumulative lesion area
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Outcome_Adverse-effects
side-effect profile
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Outcome_Physical
of cold sores to ulcerative lesions
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Outcome_Physical
cumulative lesion area
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Participant_Condition
herpes simplex labialis
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Participant_Sample-size
2437
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Participant_Condition
history of HSL