Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents
- Registration Number
- NCT00375570
- Lead Sponsor
- Medivir
- Brief Summary
The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent herpes labialis in adolescents.
- Detailed Description
The objective of the study was to evaluate the safety of ME-609 for the treatment of herpes labialis recurrences in immunocompetent adolescents, 12 - 17 years of age, following a 5-day treatment with 5-time daily topical administration.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
Inclusion Criteria
- General good health
- History of recurrent herpes labialis with at two recurrences during the last twelve months
Exclusion Criteria
- Treatment with systemic or topical antiviral agents or steroids within two weeks prior to inclusion
- Significant skin condition that occur in the area of herpes recurrences
- Nursing or/and pregnancy
- Immunosupressed state due to underlying disease (e.g. HIV infection or concomitant treatment (e.g. cancer chemotherapy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ME-609 ME-609
- Primary Outcome Measures
Name Time Method Adverse Event 3 weeks after last dose
- Secondary Outcome Measures
Name Time Method