Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
Phase 3
Completed
- Conditions
- Herpes Labialis
- Interventions
- Registration Number
- NCT00361881
- Lead Sponsor
- Medivir
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1443
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 acyclovir in ME-609 vehicle Acyclovir in ME-609 vehicle 3 Vehicle Vehicle 1 ME-609 ME-609
- Primary Outcome Measures
Name Time Method 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. 5 days
- Secondary Outcome Measures
Name Time Method Episode duration until healing
Trial Locations
- Locations (1)
Coastal Caroline Research Center
🇺🇸Mt. Pleasant, South Carolina, United States