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

This study has been completed.
Sponsor:
Information provided by:
Medivir
ClinicalTrials.gov Identifier:
NCT00736437
First received: August 14, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Herpes Labialis
Drug: ME-609
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis

Resource links provided by NLM:


Further study details as provided by Medivir:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 417
Study Start Date: August 1999
Study Completion Date: August 2000
Primary Completion Date: August 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ME-609
Drug: ME-609
Cream applied topically 6 times daily over the UVR exposed area
Placebo Comparator: 2
Vehicle
Drug: Vehicle
Treatment applied 6 times daily over the UVR exposed area

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736437

Sponsors and Collaborators
Medivir
Investigators
Principal Investigator: Spotswood L Spruance, MD University of Utah
  More Information

No publications provided

Responsible Party: Borje Darpo, MD, PhD, Medivir
ClinicalTrials.gov Identifier: NCT00736437     History of Changes
Other Study ID Numbers: 98-609-013
Study First Received: August 14, 2008
Last Updated: August 14, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivir:
UV-induced
Herpes labialis
time to healing

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 April 17, 2014