Back to resultsEfficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis
Primary Purpose
Herpes Labialis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ME-609
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Labialis focused on measuring UV-induced, Herpes labialis, time to healing
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
ME-609
Vehicle
Outcomes
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00736437
Brief Title
Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis
Official Title
Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
August 2000 (Actual)
Study Completion Date
August 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medivir
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis
Keywords
UV-induced, Herpes labialis, time to healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
417 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ME-609
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
ME-609
Intervention Description
Cream applied topically 6 times daily over the UVR exposed area
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Treatment applied 6 times daily over the UVR exposed area
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spotswood L Spruance, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis
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