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

Sponsor:	Medivir
Collaborator:	-
Information provided by:	Medivir
ClinicalTrials.gov Identifier:	NCT00361881

Purpose

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.

Condition	Intervention	Phase
Herpes Labialis	Drug: ME-609 Drug: acyclovir in ME-609 vehicle Drug: Vehicle	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Cold Sores Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Further study details as provided by Medivir:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Episode duration [ Time Frame: until healing ] [ Designated as safety issue: No ]

Enrollment:	1443
Study Start Date:	July 2006
Study Completion Date:	December 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 ME-609	Drug: ME-609 Cream, dose 5 times daily during 5 days.
Active Comparator: 2 Acyclovir in ME-609 vehicle	Drug: acyclovir in ME-609 vehicle Dose 5 times daily for 5 days
Placebo Comparator: 3 Vehicle	Drug: Vehicle Dose 5 times daily for 5 days

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361881

Locations

United States, South Carolina
Coastal Caroline Research Center
Mt. Pleasant, South Carolina, United States, 29464

Sponsors and Collaborators

Medivir

-

Investigators

Principal Investigator:

Christopher M Hull, MD

More Information

No publications provided by Medivir

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Sep 20.

Responsible Party:	Börje Darpö, MD, PhD, Medivir AB
ClinicalTrials.gov Identifier:	NCT00361881 History of Changes
Other Study ID Numbers:	609-04
Study First Received:	August 8, 2006
Last Updated:	August 14, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases

Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012