Back to resultsSafety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents
Primary Purpose
Herpes Labialis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ME-609
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Labialis
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
ME-609
Outcomes
Primary Outcome Measures
Adverse Event
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00375570
Brief Title
Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents
Official Title
An Open Label, Multi-Centre, Phase III, Subject Initiated Safety Study of ME-609 in Treatment of Recurrent Herpes Simplex Labialis in Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medivir
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ME-609
Intervention Type
Drug
Intervention Name(s)
ME-609
Intervention Description
Topical treatment 5 times daily for 5 days
Primary Outcome Measure Information:
Title
Adverse Event
Time Frame
3 weeks after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Strand, MD PhD
Organizational Affiliation
Department of Medical Sciences, Dermatology and Venereology University Hospital, Uppsala, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents
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