Herpes Labialis Clinical Trial
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
Verified date | August 2008 |
Source | Medivir |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1443 |
Est. completion date | December 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Coastal Caroline Research Center | Mt. Pleasant | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medivir |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Episode duration | until healing | No |
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