Official Title: “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”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2007

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • ME-609
• Active Comparator: 2
  • Acyclovir in ME-609 vehicle
• Placebo Comparator: 3
  • Vehicle

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Episode duration
  • Time Frame: until healing
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Medivir

Overall Clinical Trial Officials and Contacts

Christopher M Hull, MD Principal Investigator Unaffiliated  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00361881

Study ID Number: 609-04

ClinicalTrials.gov Identifier: NCT00361881

Health Authority: United States: Food and Drug Administration