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Completed

NCT Number: NCT00361881

Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of 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.

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Key information

Conditions

Herpes Labialis DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Lip Diseases Mouth Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Coastal Caroline Research Center

Mt. Pleasant, South Carolina, 29464, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ME-609

Drug

Cream, dose 5 times daily during 5 days.

acyclovir in ME-609 vehicle

Drug

Dose 5 times daily for 5 days

Vehicle

Drug

Dose 5 times daily for 5 days

Primary outcomes

  1. 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

Secondary outcomes

  1. Episode duration

    Time frame: until healing

Sponsors and collaborators

Lead sponsor

Medivir

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 9, 2006
Registry last updated
Aug 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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