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

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

MedlinePlus related topics:

Herpes Simplex

ChemIDplus related topics:

Acyclovir Acyclovir sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

More Information

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

Study placed in the following topic categories:

Mouth Diseases

Virus Diseases

Herpes Simplex

Skin Diseases, Infectious

Acyclovir

Skin Diseases

DNA Virus Infections

Stomatognathic Diseases

Recurrence

Herpesviridae Infections

Herpes Labialis

Additional relevant MeSH terms:

Skin Diseases, Viral

Anti-Infective Agents

Therapeutic Uses

Antiviral Agents

Lip Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Medivir -
Information provided by:	Medivir
ClinicalTrials.gov Identifier:	NCT00361881