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Trial record 54 of 115 for:    acyclovir

Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00361881
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : August 18, 2008
Sponsor:
Information provided by:
Medivir

Tracking Information
First Submitted Date  ICMJE August 8, 2006
First Posted Date  ICMJE August 9, 2006
Last Update Posted Date August 18, 2008
Study Start Date  ICMJE July 2006
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
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. [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00361881 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
Episode duration [ Time Frame: until healing ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Herpes Labialis
Intervention  ICMJE
  • Drug: ME-609
    Cream, dose 5 times daily during 5 days.
  • Drug: acyclovir in ME-609 vehicle
    Dose 5 times daily for 5 days
  • Drug: Vehicle
    Dose 5 times daily for 5 days
Study Arms  ICMJE
  • Experimental: 1
    ME-609
    Intervention: Drug: ME-609
  • Active Comparator: 2
    Acyclovir in ME-609 vehicle
    Intervention: Drug: acyclovir in ME-609 vehicle
  • Placebo Comparator: 3
    Vehicle
    Intervention: Drug: Vehicle
Publications * Hull CM, Harmenberg J, Arlander E, Aoki F, Bring J, Darpö 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2008)
1443
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00361881
Other Study ID Numbers  ICMJE 609-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Börje Darpö, MD, PhD, Medivir AB
Study Sponsor  ICMJE Medivir
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher M Hull, MD
PRS Account Medivir
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP