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

Information source: Medivir
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Labialis

Intervention: ME-609 (Drug); acyclovir in ME-609 vehicle (Drug); Vehicle (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Medivir

Official(s) and/or principal investigator(s):
Christopher M Hull, MD, Principal Investigator

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.

Clinical Details

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

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

Primary outcome: 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.

Secondary outcome: Episode duration

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Coastal Caroline Research Center, Mt. Pleasant, South Carolina 29464, United States
Additional Information

Starting date: July 2006
Last updated: August 14, 2008

Page last updated: August 23, 2015

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