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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00736437 |
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Date of registration:
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14/08/2008 |
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Primary sponsor: |
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Public title:
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Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis
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Scientific title:
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Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis |
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Date of first enrolment:
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August 1999 |
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Target sample size:
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417 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00736437 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Contacts
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Name:
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Spotswood L Spruance, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Utah |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Herpes Labialis
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Intervention(s)
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Drug: ME-609
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Drug: Vehicle
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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98-609-013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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