Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
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
1 other identifier
interventional
1,443
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 8, 2006
CompletedFirst Posted
Study publicly available on registry
August 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedAugust 18, 2008
August 1, 2008
1.1 years
August 8, 2006
August 14, 2008
Conditions
Outcome Measures
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.
5 days
Secondary Outcomes (1)
Episode duration
until healing
Study Arms (3)
1
EXPERIMENTALME-609
2
ACTIVE COMPARATORAcyclovir in ME-609 vehicle
3
PLACEBO COMPARATORVehicle
Interventions
Eligibility Criteria
You may qualify if:
- Generally good health
- History of recurrent herpes labialis with at last three episodes during the prior 12 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medivirlead
Study Sites (1)
Coastal Caroline Research Center
Mt. Pleasant, South Carolina, 29464, United States
Related Publications (1)
Hull CM, Harmenberg J, Arlander E, Aoki F, Bring J, Darpo B, Levin MJ, Tyring S, Spruance SL; ME-609 Study Group. Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial. J Am Acad Dermatol. 2011 Apr;64(4):696.e1-11. doi: 10.1016/j.jaad.2010.08.012. Epub 2010 Sep 20.
PMID: 20851499DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher M Hull, MD
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2006
First Posted
August 9, 2006
Study Start
July 1, 2006
Primary Completion
August 1, 2007
Study Completion
December 1, 2007
Last Updated
August 18, 2008
Record last verified: 2008-08