Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis

Medivir1,443 enrolled

Overview

The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.

This was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of ME-609, acyclovir in ME-609 vehicle, and vehicle alone. Treatment was subject-initiated within 1 hour of experiencing the first signs or symptoms of a herpes recurrence. The subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,443

Conditions

Herpes Labialis

Interventions

ME-609DRUG

Cream, dose 5 times daily during 5 days.

acyclovir in ME-609 vehicleDRUG

Dose 5 times daily for 5 days

VehicleDRUG

Dose 5 times daily for 5 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Generally good health * History of recurrent herpes labialis with at last three episodes during the prior 12 months Exclusion Criteria: * Treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization * Pregnant and/or nursing women * Continuous daily treatment with pain medication * Significant skin condition that occur in the area of herpes recurrences

Locations (1)

Coastal Caroline Research Center

Mt. Pleasant, South Carolina, United States

Outcomes

Primary Outcomes

Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage.

Time frame: 5 days

Secondary Outcomes

Episode duration

Time frame: until healing

Data from ClinicalTrials.gov

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