Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis

August 14, 2008 updated by: Medivir
The primary objective was to compare the efficacy of ME-609 cream vs placebo cream on the time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions experimentally induced after ultra violet radiation (UVR) exposure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective was to compare the efficacy of ME-609 cream vs placebo cream on the time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions experimentally induced after ultra violet radiation (UVR) exposure. Secondary objectives were to compare the time to normal skin, incidence of lesion development (number and type of lesions), maximum lesion size, length of lesion stages, frequency/severity/duration of pain, frequency/severity/duration of tenderness, redness and/or oedema in the UVR exposed area, frequency of virus positive lesions, time to cessation of viral shedding and safety of ME-609 cream vs placebo cream.

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 years or older
  • A history of reactivation of recurrent herpes labialis with overexposure to sunlight in the last 12 months, or 2 or more cold sore lesions in the last 12 months
  • Generally healthy as determined by medical history and verbal interview
  • Females who were still able to conceive were to have had a negative pregnancy test on enrolment
  • Fritzpatrick skin type category of I to IV

Exclusion Criteria:

  • Previous inclusion in this study

    • Participation in clinical investigational drug studies in the 4-week period prior to enrolment
    • Participation in any herpes UVR reactivation study within the previous 3 months
    • Previous herpes vaccination at any time
    • Occurrence of herpes labialis (end of episode) within one month prior to enrolment
    • Inflammatory, congenital or iatrogenic underlying immunodeficiency disorders
    • Use of topical steroids in or near the face or on the forearms, systemic steroids (within 30 days from enrolment) or anti-inflammatory drugs (within 10 days from enrolment)
    • Women who were pregnant, lactating or breast feeding
    • Women of child bearing potential not using adequate contraception as judged by the investigator
    • Recent history of alcohol or drug abuse which in the opinion of the investigator could interfere with compliance
    • Significant skin disease such as atopic dermatitis or eczema, that would interfere with the assessment of lesions
    • Allergy or hypersensitivity to steroids, acyclovir, penciclovir and/or other nucleoside analogues
    • Administration of any drug commonly associated with photosensitivity (tetracycline, Retin A) within one week of UVR exposure
    • Any antiviral therapy within 14 days prior to enrolment
    • History of allergy or sensitivity to sunscreen
    • History of herpes keratitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Vehicle
Drug: Vehicle
Treatment applied 6 times daily over the UVR exposed area
Experimental: 1
ME-609
Drug: ME-609
Cream applied topically 6 times daily over the UVR exposed area

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions experimentally induced after ultra violet radiation (UVR) exposure.
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
time to normal skin, incidence of lesion development, max lesion size, length of lesion stages, pain and tenderness, redness and/or oedema in the UVR exposed area, frequency of virus positive lesions, time to cessation of viral shedding and safety
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medivir

Investigators

  • Principal Investigator: Spotswood L Spruance, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Primary Completion (Actual)

August 1, 2000

Study Completion (Actual)

August 1, 2000

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

August 15, 2008

Last Update Submitted That Met QC Criteria

August 14, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-609-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Herpes Labialis

Clinical Trials on ME-609

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe