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

Medivir

Status and phase: Completed; Phase 3

Conditions: Herpes Labialis

Treatments: Drug: Vehicle; Drug: ME-609; Drug: acyclovir in ME-609 vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00361881

609-04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,443 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,443 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

ME-609

Treatment:

Drug: ME-609

2

Active Comparator group

Description:

Acyclovir in ME-609 vehicle

Treatment:

Drug: acyclovir in ME-609 vehicle

3

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: Vehicle