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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00361881
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : August 18, 2008
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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.

Condition or disease Intervention/treatment Phase
Herpes Labialis Drug: ME-609 Drug: acyclovir in ME-609 vehicle Drug: Vehicle Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : July 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: ME-609
Cream, dose 5 times daily during 5 days.

Active Comparator: 2
Acyclovir in ME-609 vehicle
Drug: acyclovir in ME-609 vehicle
Dose 5 times daily for 5 days

Placebo Comparator: 3
Drug: Vehicle
Dose 5 times daily for 5 days

Primary Outcome Measures :
  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 Outcome Measures :
  1. Episode duration [ Time Frame: until healing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00361881

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United States, South Carolina
Coastal Caroline Research Center
Mt. Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
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Principal Investigator: Christopher M Hull, MD

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Börje Darpö, MD, PhD, Medivir AB Identifier: NCT00361881     History of Changes
Other Study ID Numbers: 609-04
First Posted: August 9, 2006    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: August 2008
Additional relevant MeSH terms:
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Herpes Simplex
Herpes Labialis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents