Herpes Labialis
Conditions
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.
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.
Interventions
DRUGME-609
Cream, dose 5 times daily during 5 days.
DRUGacyclovir in ME-609 vehicle
Dose 5 times daily for 5 days
DRUGVehicle
Dose 5 times daily for 5 days
Sponsors
Medivir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Episode duration | until healing |
Countries
United States
Outcome results
None listed