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

Herpes Labialis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361881
• Other study ID #: 609-04
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2006
• Last updated: August 14, 2008
• Start date: July 2006
• Est. completion date: December 2007

Study information

• Verified date: August 2008
• Source: Medivir
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1443
• Est. completion date: December 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Labialis
• Herpes Simplex

Intervention

Drug:
• ME-609
Cream, dose 5 times daily during 5 days.
• acyclovir in ME-609 vehicle
Dose 5 times daily for 5 days
• Vehicle
Dose 5 times daily for 5 days

Locations

Country	Name	City	State
United States	Coastal Caroline Research Center	Mt. Pleasant	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medivir

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Episode duration		until healing	No