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

NCT ID: NCT00361881

Last Updated: 2008-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1443 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Herpes Labialis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

ME-609

Group Type EXPERIMENTAL

ME-609

Intervention Type DRUG

Cream, dose 5 times daily during 5 days.

2

Acyclovir in ME-609 vehicle

Group Type ACTIVE_COMPARATOR

acyclovir in ME-609 vehicle

Intervention Type DRUG

Dose 5 times daily for 5 days

3

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Dose 5 times daily for 5 days

Interventions

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ME-609

Cream, dose 5 times daily during 5 days.

Intervention Type DRUG

acyclovir in ME-609 vehicle

Dose 5 times daily for 5 days

Intervention Type DRUG

Vehicle

Dose 5 times daily for 5 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medivir

INDUSTRY

Sponsor Role lead

Responsible Party

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Medivir AB

Principal Investigators

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Christopher M Hull, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Coastal Caroline Research Center

Mt. Pleasant, South Carolina, United States

Site Status

Countries

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United States

References

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Hull CM, Harmenberg J, Arlander E, Aoki F, Bring J, Darpo 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.

Reference Type DERIVED
PMID: 20851499 (View on PubMed)

Other Identifiers

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609-04

Identifier Type: -

Identifier Source: org_study_id