NCT00361881

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

A Randomized, Double-Blind, Active Controlled, Vehicle-Controlled, Subject Initiated Study Comparing Efficacy and Safety of ME-609 Versus Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,443 (actual)
• Sponsor: Medivir · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
DRUG	ME-609	Cream, dose 5 times daily during 5 days.
DRUG	acyclovir in ME-609 vehicle	Dose 5 times daily for 5 days
DRUG	Vehicle	Dose 5 times daily for 5 days

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-08-01
• Completion: 2007-12-01
• First posted: 2006-08-09
• Last updated: 2008-08-18

Locations

1 site across 1 country: United States